Professional Documents
Culture Documents
Customers come first
Three attachments:
Corrective Action Report Design Note Customer Letter
Section A: Details
® ® ®
This FCA applies only to current systems which have a single computer (PC) connected to three or four VITEK 2, VITEK 2 XL, or VITEK 2
Compact instruments.
An investigation has determined that the configuration described in the both the VITEK 2 and VITEK 2 XL Integrated System Service Manual
(510726‐5EN1), and the VITEK 2 Compact Service Manual (510779‐5EN1), may create a condition where an instrument message sent through
a Sea‐level USB Serial Adaptor may not immediately be seen by the VITEK 2 software. If this occurs, the readings are deemed as “missed” by
the software, and card analysis for the corresponding card stops. All cards not impacted are processed and finalized as intended by the VITEK 2
system.
The symptoms typically reported by the customer are as follows:
The card remains in the VITEK 2 incubator until maximum incubation time, and then ejects from the instrument.
Within the software the card remains in preliminary status, and the user must delete the card.
(click on the paper clip icon)
Corrective Action Report
Correction Action:
Field Service personnel should perform the attached Design Note 12‐008 VITEK 2 Systems Multiple Instrument Configuration, at the next
scheduled Preventive Maintenance (PM). This Design Note describes how to change the instrument cable connections and configure the PC
COM ports, so all of the data cables are connected to the back of the PC and all of the diagnostics cables are connected to the Sea‐level USB
Serial Adapter.
This Design Note supersedes the PC connection instructions for three or four instruments published in the “VITEK 2 and VITEK 2 XL Integrated
System Service Manual” (510726‐5EN1), and the “VITEK 2 Compact Service Manual” (510779‐5EN1). Future installations of three or four
instruments connected to one PC should also be performed by referencing the attached Design Note, however they are not part of this FCA.
(click on the paper clip icon)
Design Note 12‐008
Product Description
VITEK 2 60, XL or VITEK 2 Compact system configurations with three or four instruments connected to one PC.
Number: 1311 Title: FCA VITEK®2, VITEK® 2 XL and VITEK®2 Compact Instrument Connectivity Issue INTERNAL USE ONLY Page 1 of 8
004045 ‐ Rev 01.A ‐ Field Action Notification Communication Forms ‐ FCA ‐ en ‐ Editable.doc
Product Distribution
All subsidiaries and distributors with VITEK 2 Systems installed.
Customer Letter
The FSE must provide the attached customer letter (P/N 702660‐1) when Design Note 12‐008 is executed.
(click on the paper clip icon)
Customer Letter
Implementation
• Each bioMérieux support personnel must review this FCA, Corrective Action Report, Design Note, and the Customer Letter.
• Perform Design Note 12‐008 at the next scheduled PM. If the customer does not have a service agreement, Design Note 12‐008 must be
performed by the FCA deadline (15‐May‐2013).
• If customer reports the symptoms listed in this FCA prior to their scheduled PM, FSE should perform Design Note 12‐008 during the
responding service visit.
• The FSE must provide the Customer Letter to the customer for either of the above reasons.
Section B: Required Actions
1. Immediately, sign and return Sections 1 and 2 of the Acknowledgement Form (Section E of this FCA) by e‐mail to
ccmc_management@biomerieux.com or by fax to + 33 478 87 21 79.
2. Modify the customer letter to include the your local phone number and contact information.
A local contact person’s name and signature can be added, if desired.
Translate the customer letter, if necessary.
Modify the clinical letter as necessary for INDUSTRY customers using terminology applicable for food, pharmaceutical or veterinary
laboratories.
3. Please read the Corrective Action Report and determine if your competent authority should be notified. The Health Hazard
Assessment is included in the report. This document is for INTERNAL USE ONLY. This FCA is not reportable to the FDA. If you need
assistance with the decision whether to report this issue to your competent authority, please contact Ryan Lemelle, Corporate
Regulatory Compliance (ryan.lemelle@biomerieux.com)
4. Complete Section 1, Section 3 items 12 and 15, and section 4 of the Acknowledgement Form, after you have performed Design
Note 12‐008 on each affected system and provided the customer letter to your customers. Return by e‐mail to
ccmc_management@biomerieux.com or by fax to +33 478 87 2179. Include your current VITEK 2 customer list and your local
letter. A customer acknowledgement form was not included with the customer letter. It is up to your local RA/QA representative
to determine if customer acknowledgement is required.
5. Completion Deadline: All activity must be completed by 15‐May‐2013.
Section C: Contact Information
℡ +1 314 506 8066 +1 919 470 6818 @ CCMC_VITEK@biomerieux.com www gcs.biomerieux.fr
Section D: GDF Distribution
This FCA is being distributed to all countries registered on the GCS Portal GDF Distribution Tool to receive Field Corrective Actions for
VITEK 2 and VITEK 2 Compact Clinical and INDUSTRY.
• Range Codes selected :C20 KC1 ‐ VITEK 2, C57 KC1 ‐ VITEK 2 COMPACT
Number: 1311 Title: FCA VITEK®2, VITEK® 2 XL and VITEK®2 Compact Instrument Connectivity Issue INTERNAL USE ONLY Page 2 of 8
004045 ‐ Rev 01.A ‐ Field Action Notification Communication Forms ‐ FCA ‐ en ‐ Editable.doc
• Countries : Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Benin (People*s Republic of ),
Bhutan, Bolivia, Bosnia Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Burkina‐Faso, Cambodia, Cameroon (United Republic of ), Canada, Chad,
Chile, China, Colombia, Congo, Congo (Democratic Republic of ), Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt,
El Salvador, Eritrea, Estonia, Ethiopia, France, French Guiana, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guam, Guatemala, Guinea,
Honduras, Hungary, Iceland, India, Indonesia, Irak, Iran, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Laos, Latvia,
Lebanon, Libya, Lituania, Macedonia, Malaysia, Mali, Malta, Martinique, Mauritania, Mexico, Mongolia, Montenegro, Morocco, Mozambique,
Myanmar, Nepal, Netherland West Indies, Netherlands, New Caledonia, Nicaragua, Niger, Nigeria, Oman (The Sultanate of ), Pakistan, Palestine,
Panama, Paraguay, Peru, Philippines, Poland, Polynesia (French), Portugal, Puerto Rico, Qatar, Reunion Island, Romania, Russia, Saint Pierre and
Miquelon, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria,
Tanzania (United Republic of ), Thailand, Togo, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, United States of
America, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe
Subsidiaries distribution List
Group Companies Main addressees (to:) Copy List (cc:)
Amine Elhocine ATEK, Lamia TITEM, Karim Nadia OKA,
Algeria
IKROUBERKANE,
Argentina Rossana BUFFETTI, Karina BOMBICINO, Rosana LABAT, Pedro DI ROCCO, Rosana ZUDIKER,
Louise LONGHURST, Peter MORRIS, Vijay Merrilyn COLUSSI, Ben ROGERS,
Australia
GUBBI,
Anna BERGER, Klaudia PIGEL, Lambe Christian ROJS, Michaela KULAWIKOVA, Eva GAPPMEIER, Bettina GUGLIA, Norbert
Austria MATOVSKI, BIRICZ, Olivier CARTERET, Elisabeth KRUTISCH, Evelyn LEITNER, Peter VALENTA,
Marianne HERLBAUER, Mario MENAPACE, Thomas MUELLER, Predrag MASIC,
Bie VAN GIJSEGEM, Catherine RUYTINX, Dimitri BROES, Herve BACHELEY, Francis BAUDOUX, Marianne
Belgium
POLET, Nadia AELBRECHT,
Marcus‐Vinicius SANTOS, Pedro DI ROCCO, Suelen SILVA, Sandra REGINA, David MARTINEZ, Patricia MORAIS,
Brazil
Arrenaldo TEIXEIRA, Maria‐Fernanda AREAL,
Canada Shirley FREDETTE, Xavier NOUVELOT, Carmen LOUMI, Catherine DEPATIE, Francois TURGEON, Jean‐Simon ROY,
Chile Francisco MUNOZ, Alejandra ARRUE,
CNCustomerService@biomerieux.com, Bin SHEN, James SHIU, MingGang GUO, Michael CHEUNG, Jerry HSU, Rachel HUANG,
William SO, Crolles HUANG, Jason LU, David CHI, Pascal VINCELOT, Ruike YAN , Weiwei
WANG, Yijun ZHANG, Jiafeng LUO, Yaowei LI, Rong ZOU, Sarah YANG, Nicko LEUNG, Bin
ZHANG, Bin XIONG, Lu GUO, Shudan CHEN, Jean WANG, Jian GUO, Fabrice MASSON,
China
Bede LAU, Julia ZHOU, GuoHua SONG, Hongmeng YANG, Ray WANG, Qizhi LIAO, Nuno
REIS, Shuang ZHANG, Junmin ZHANG, Jerry SU, Vincent CHAN, Laurence GAUTHIER,
Steven LI, Cathy JIN, David LAU, Rachel TIAN, Celine CHENG, James HUANG, Grace
GUO,
Sandra ZAMBRANO, Andres MONGUI,
Colombia
Monica GUTIERREZ, Glen Oscar ORTEGA,
Jiri CHADT, Martin PATEK, Hynek PRUKNER, Marek URBANEK, Petr MAN, Eva JERABKOVA, Martina LOSKOTOVA, Kamila KRIZOVA,
Czech Republic
Jolana MARTINSKA,
Christian ROBERT, Marie‐Therese Cecile TERRIER EMERY, Annie BERTRAND, Guillaume EYNARD, Jacques SAINT FELIX,
France KERANGUEVEN, Bruno FAIVRE, Alain SUCCA, Nathalie IORI, Romuald COURTADE, Jean‐Michel BEUCHER, Philippe BECHAUD, Gildas
Rachel METRA, FURET,
CS.germany@biomerieux.com, Kerstin KUESSNER, Ingrid GUMBRECHT, Bernd JUNG, Katharina KAEHLER, Bjoern
Germany
BRETH,
Elsa MARGARITI, Vagelis ZACHARIS, Vassilios SCHINAS, Tania GEROMERIATI, Nikolaos PAPAZOGLOU, Angeliki KARAVA,
George TZAILOPOULOS, Eleni MORAITI, Stathis CHORIANOPOULOS, Konstantinos
KAROUNTZOS, Katerina STAVRAKOPOULOU, Theodoris PAPAGRIGORIS, Vassilis
Greece ARVANITIDIS, Stavros ANAGNOSTOPOULOS, Nikolaos EYSTATHIADIS, Vassilios FAKAS,
Michael FINTIKAKIS, George DIMITRELOS, John KALABALIKAS, John DALAKOURAS,
Kleanthis TSOLIS, Theodoros ZIGRAS, Theodora PAKTITI, Paris KARATZETZOS, Aikaterini
KONTINOPOULOU, Stamatis STAMATIS,
Orsolya SZABO, Timea MESTER, Krisztina OSVATH, Judit JUHASZ, Gyorgy PATAKY, Arpad BENJAMIN,
Hungary
Jozsef POECZE,
Bhargab BARUA, Suresh KUMAR, Daraius Biswajyoti MISRA, Rekha KHANNA, Ghanshyam LAHOTI, Bivash CHAKRABORTY, Dr.
India
MORAWALA, Deepak WADHWA, J MANOJ, Navjeet SINGH, Revathy SREEKUMAR, Aanchal ARORA,
Massimo RICCI, Silverio BOTTINI, Cristina Mario BONATTI, Yasha MITROTTI, Anna QUAGLIERI,
Italy OLDANI, Elena GRANDINI, Simone
PAGLIERINI,
Ivory Coast Cristelle SAWADOGO, Pacy‐Love DIAFOUKA,
Tatsuo SHINKI, Shigenori YAMAGUCHI, Akira MIYAZAKI, Kenichi ETO, Makiko NAKAMURA, Kazuyuki TAKAHASHI, Yasuko
Japan Sachie SEKIGUCHI, Takeshi KOBAYASHI, FUSHITANI, Thor BERG,
Kazuyuki UCHIDA, Sayuki MATSUMOTO,
Jung‐hee LEE, Seung Yeun CHOI, Ki‐Jae CHO, Ki‐Hyoung LEE, Jong Woo LEE, Dong Heon BANG, CD KIM, Dae Ho SONG,
Korea
Seung il YANG, Bae Sung KIM,
Mexico Brenda MARRON, Veronica LOPEZ,
004045 ‐ Rev 01.A ‐ Field Action Notification Communication Forms ‐ FCA ‐ en ‐ Editable.doc
Group Companies Main addressees (to:) Copy List (cc:)
Alejandro RODRIGUEZ, Silvia RANGEL, Iliana
REYES, Ninoska CASTILLO, Marco HERRERA,
Fabricio RANGEL, Miguel VILLA, Massiel
ANGELES, Jose OLMOS, Susana SERRANO,
Martha ORTIZ,
Middle East Hussein ABHARI, Nora DAHSHE, Ismail KHALIFA, Lowana AWAD, Khaled HAMED, Qusai AL SAYYED,
Ard KAPPE, Nathalie CLERMONT, Corry VAN OOIJEN, Anja BOEREFIJN, Ton SMEETS, Herve
Netherlands customer.service.benelux@biomerieux.com, BACHELEY, Peter MEIJER,
Bie VAN GIJSEGEM,
Nordic Countries custservice.nordic@biomerieux.com,
Poland Ewa PERELKIEWICZ, Artur JURZYNSKI, Dorota PAWLUCH, Piotr SZCZEGLOW,
Portugal CS.Portugal@biomerieux.com, Luis ANDRADE, Antonia NASCIMENTO,
Oksana SHELEMEKH, Anton LYSENKO, Vladimir ZURA, Mihail KUZNETSOV , Yury CHUDINOV, Natalia GUSEVA, Andrey PAVLOV,
Valeria VARAKSINA, Denis BALASHOV, Yury TOPORISCHEV, Anna LESHUKOVA, Alexander SHURUBNEV, Sergey RUSINOV,
Russia
Tatiana DUSHKINA, Alexandr LEONOV, Vanda PANNA,
Tatyana ROSLAVTSEVA,
Shu Yeong QUECK, Martes GANADEN, Janine Darshna TANNA, David LING, Grace CHA, Dung NGUYEN SY, Noel WENTWORTH,
Singapore
ELLIOTT, Jeff Jing LI, Sean MAYNARD,
Umesh LALLOO, Priyesh BHOORA, Alfie Karren IMESON, Alfredo GIANGREGORIO, Vinny GOVENDER, Hesham JAIRAM, Terrence
South Africa
CLARKE, KHOZA, Jerry MNGUNI, Peter RECORDS, MacDonald SIBIYA, Andre VAN DER MERWE,
Francisco PONZ, Agustin GARCIA, Paloma MARTINEZ, Ana Isabel MATA, Juan‐Jose PARRA, Pilar DIAZ LOPEZ, Maria‐
Spain
Antonia CAMACHO,
Philippe VINCENT, Deborah GOSTELI Philippe JOBIN, Andreas GROSSE, Isabelle HIRTER, Jacqueline ZOLLINGER, Benoit
Switzerland
CAMOIS, Anaele SIMON, Nicola UEBERSAX, TEISSIER, Robert LEHMANN, Roman WANNER, Norbert HEGGLIN, Susan SCHWAIGER,
Bunjong PIYAKULPRADIT, Jatuporn Brett CRAWLEY, Bunjerd SUANPROM, Waraporn POOLSIRIWANNA,
Thailand
SUPAREE,
Oktay HAFIZOGLU, Pinar SAYAR, Yucel ISKEN, Oya AKCELIK, Can ORHUN, Can AYDOGAN, Dursun CAVUS, Tolgay KORKUT,
Nuran AKKAYA, Mehmet BAYSAL, Hasan BILGEHAN, Ilhan KELOGLU, Huseyin SAG, Irfan
Turkey
CAKIROGLU, Abdulkerim ERGEN, Ahmet SUEL, Yavuz BARBAROS, Irem EGITIMCI, Canan
KIZILKAYA,
UK Diarmuid LEE, Sheila MARSH, John BAGSHAW, Chris WELLS, Cliff LIDDLE, Christie DOWNING‐KAY,
Nathan HARDESTY, Frank CROUT, Ed Dave MANLEY, Nedal SAFWAT, Karen CAIN, Dennis PEGRAM, Kyle BARNES, Becci
KLOSTERMAN, MELLIN, Tom OBRIEN, Ray TURNLEY, Will DIGGS, Jackie FRENCHIE, Nancy WEAVER, Lisa
USA
DEGEN, Sue SHIMA, Bob KORMAN, Rick HICKS, Pierre‐Louis THINEY, Steve RATERS, Dale
MOORE, Dan BIONDO, Shereese MCCONNELL, Debbie SMITH, Alan BERGOLD,
Fumiko KINO, Takeo NAKATA, Takao Ryoji HISHIKAWA, Yuichi YAJIMA, Kazumasa FUKUMORI, Etsumasa WADA, Toshikazu
SYSMEX SHIMADA, Hiroyuki TAKAMOTO, Hisashi YAMAGISHI, Hiroshi YAMANE, Shinichi OGINO,
YAMAGATA, Yoshihisa GOTO,
Distributors distribution List
Companies Countries Main addressees (to:) Copy List (cc:)
Croatia Ankica ADJUKOVIC, Ivana Klaudia PIGEL,
ZARKO, Tanja KLJAJIC,
A & B
Andrija KRALJ, Tomislav
BABIC,
Access BioTech Ltd Bangladesh Abdul BAYES,
Oman (The Sultanate of ) Suresh GANDHI, Saurabh DUBEY, Dittu MANAPARAMBIL, Jayant
AL HASHAR PHARMACY
MANGLURKAR, Anil PADMANABHAN,
United Arab Emirates Anwar ABU EIDA, Jaber ABIDRABBU ALI ABEDAL, Khaled ABDULKAREEM,
AL‐HAYAT Rani AHMAD, Zayed AL TAWEEL, Mohammed EL ZAQ,
PHARMACEUTICALS Atul GUPTA, Husam KHALIL, Arafat M.M. ZALLOUM,
Mahdie MANSOUR, Ahmad S.AHMAD, Saad ZAITOUN,
Saudi Arabia Jamal ABDUL FATTAH, Eyad ZIYADAH, Yahya AHMAD, Azmi ANSHASI, Abdullah
Samer AL KOLAK, ALJUNDI, Mokhtar GHAMOUGUI, Ghaleb HAIKAL, Ahmed
AL‐JEEL MEDICAL & JAMIL, Khaled JIJAWI, Hamzeh MATAR, Naser MOMANI,
TRADING Ahmad NAVEED, Kamal SAWALHA, Yahia HASAN, Rabee
KANANI, Ibrahim BITAWI, Mohd BANNA, Khaled ANSARI,
Mohd SHAMARI, Feras KHALIL,
ALI ALSUWAIDI TRADING Qatar Ali AL SUWAIDI, Emam KHALIL, Sathyam HARIHARAN, Cielito SALAMAH,
EST
Turkmenistan Karine AYRIYEVA, Jennet
ANNATACH NAZAROVA, Denis
KOZINSKIY,
BADER SULTAN & BROS.CO Kuwait Ahmad AL GHOUL, Haitham Jon RIDAD DELAPAZ, Rania FAZA,
004045 ‐ Rev 01.A ‐ Field Action Notification Communication Forms ‐ FCA ‐ en ‐ Editable.doc
Companies Countries Main addressees (to:) Copy List (cc:)
AL BAGHDADY, Hisham
EZZAT,
BGL SYSMET Benin (People*s Republic of ) Pierre CAPOCHICHI, Rene ALLAKPATO, Cristelle SAWADOGO,
BGL Sysmet Togo Monkpokpo ADJOTIN, Rene ALLAKPATO, Cristelle SAWADOGO,
Ivory Coast Jean‐Paul AHOUTI, Ahmed DIOMANDE, Cristelle SAWADOGO, Marie‐
BIOSYNERGIE
Chantal NIACADIE,
Lebanon Mohammad JAWHAR, Pierre SALLOUM, Stephanie SALLOUM, Diana NASR,
Hassan TABBARAH, Pierre CHANAA, Roula MOHAMMAD,
BIOTECK Mohammad DAABOUL, Rabih NASSAR, Rami RACHID,
Bassam BAGHDADI, Hanaa FAYAD, Fares FARES, Bassam
RABAH,
Macedonia Gabriela TASEVSKA, Klaudia PIGEL, Riste SOSKOVSKI, Makedonka
BIOTEK
STEFKOVSKA, Katerina JANKOVSKA,
Reunion Island Olivier BAWEDIN, Bruno
BIOTOP LA REUNION
FAIVRE, Alain SUCCA,
BIOTOP ANTILLES Martinique Alain SUCCA, Bruno FAIVRE,
BIOTOP ANTILLES Guadeloupe Bruno FAIVRE, Alain SUCCA,
BROMA BEL d.o.o. Bosnia Herzegovina Alenka KOSORIC,
C.I.O. & SONS MERCHANTS Nigeria Patrick OLISA,
NIG LTD (NIGERIA)
CHERUBINO LTD Malta Fiona SCHEMBRI, Donald BUTTIGIEG, Roger BARTOLO,
Armenia Bella TADEVOSYAN, Ani
Concern‐Energomash
ZOHRABYAN,
CORPORATION Bolivia Fernando GALLEGOS, Rudy MAIDA, Julio ISLA,
TRANSANDINA
COSMOS GENERAL Eritrea Saba GEBREMEDHIN, Ruth WOLDU,
TRADING & CONTRACT
Vietnam Long HUYNH VU, Luong Bui Thi Thanh HUYEN, Dung NGUYEN SY,
Deka Co Ltd.
Quang HUY,
Estonia Katrin EIMRA, Jaan
DIAMEDICA SALUVERE, Ilmar ISAKAR,
Sergei BOKOV,
Latvia Arnis OZOLS, Aigars Laura MIHAILOVSKA,
SKRUPSKIS, Imants
DIAMEDICA
PURGAILIS, Vineta
JANSONE,
Lituania Livijus MINTAUCKIS, Robertas SLEVAS,
DIAMEDICA Adomas URBANAVICIUS,
Stasys KRIZANAUSKAS,
DIAR ASSALAM MEDICAL Libya Saleh AMBARAK, Taif RAAD, Ali ELYASS, Rabia ALALAM, Mohamed ALABIB,
Ukraine Oleg YURCHENKO, Kirill Artem SLOBODYANYUK,
DiaVeritas Ltd.
VORONIN,
Europ Continents ‐ Cambodia Sun Nam SENG, Jean‐Pierre LE LAGADEC, Sournia THIBAUD,
Cambodia
Europ Continents ‐ Laos Laos Seng OUDOMMANY, Maxime ROUSSILLON,
Europ Continents ‐ Myanmar Win Kyaw OO, San San YI,
Myanmar
Netherland West Indies bulletins@caribbean‐lab‐supplies.com, Fernando
FARMINPEX N.V.
GALLEGOS, Marcelo BIRBRAYER, Marina CAPULA,
FAS Diagnostics Group, Philippines Roel DOLORES, Adonis REDILLA, Mark TUBONGBANUA,
Incorporated
Zimbabwe Mephius MAROVA, Fredrick DAHLMANN, Mufaro MAROBA, Mainford
FIMA ENTERPRISES PVT LTD MOYO, Boniface MUDENGE, Diggers MURIRA, Arther
MANDISODZA, Milkah TADYANEHONDO, Chipo PHIRI,
Venezuela Vivian VERGARA, Alberto Susanne RINKEL, Valeria IVANOVIC, Marina CAPULA,
GANBARO
CALVO, Fernando GALLEGOS,
Uzbekistan Jayanta BHATTACHARYA,
GLOBAL IMPEX Boris EREMEEV, Gulya
TURSUNOVA,
Global Marketing Services Pakistan Noman MUHAMMAD, Mubashar MUBASHAR SHAKOOR,
(G.M.S) Akram IRFAN, Sajjad Raz Naqvi SYED, Adnan JAVED,
GSM GUYANE French Guiana Alain SUCCA,
GULF PHARMACY & Bahrain Reggie DSOUZA, Veerender BHUPATHY, Ramesh GOPINATH, Siva
GENERAL STORE‐MEDICAL PRAKASH, Peter SEQUIRA, Manoj SUNDERAN,
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Companies Countries Main addressees (to:) Copy List (cc:)
& SCIENTIFIC
Mongolia Naranbaatar
GYALS Co., Ltd.
NARANBAATAR,
HASS SCIENTIFIC & Kenya Moses MESHACK, Alpha BWIRE, Moses BWIRE, James MURIUKI,
MEDICAL SUPPLIES cservice@hasscientific.com,
Mozambique Manuela AMARAL, Marco Manuel COSSA, Paula RIBEIRO, Juaila GAMA, Rodrigo
HOSPITEC FERNANDES, Antonio SANTOS,
PINHEIRO,
Israel Victor STOLYARENKO, Offer Barbara REUVENI, Hila AMIEL,
FINKELMAN, Merav ZUNTZ,
ILEX LTD
Avinoam ZOLA, Liron
WALTER,
Morocco Ahmed ACHAACH, Zakaria
HADHA, Afaf ZAHI, Fatime‐
IM ALLIANCE Ezzahra EL OUAZZANI,
Mostafa EL BAKKALI EL
HASSAN,
Bulgaria Ludmila ZAFIROVA, Konstantin DASKALOV, Klaudia PIGEL, Iordanka BICHEVA,
INTER BUSINESS 91 Ltd.
Svetlomir EMANUILOV, Daniel IVANOV,
INTERMED NOUVELLE New Caledonia Bruno FAIVRE, Alain SUCCA,
CALEDONIE
Panama Ruben DELGADO, William CHEN, Loyda ODUBER, Marcelo BIRBRAYER,
INVERSIONES SAGRAV S.A.
Marina CAPULA, Fernando GALLEGOS,
Netherland West Indies bulletins@caribbean‐lab‐supplies.com , Marcelo
ISED N.V.
BIRBRAYER, Marina CAPULA, Fernando GALLEGOS,
ISLA Puerto Rico Oscar SANTIAGO, David MARRERO,
Jordan Ahmed ABDULSALAM, Moein BARKAT, Alaa ALMASRI, Fahimeh ALSHALABI,
ISMAILCO
Raghda DABOBASH, Huda DAWAF,
Jordan Eman ALANE, Elwar Sabah Mohsen AL DULAIMI, Ahmed ALI, Esam
ALANE, Ali RASHEED, Abdulrahman MOHAMMED, Suad
ISMAILIYA TRADING
LAFTA, Mohammed HASAN, Ahmad FAISAL, Mahmood
AGENCIES
MOHAMMED, Abdulhafidh ALANI, Ammar SHAKIR, Yasir
SHAKIR,
ISMAILIYA TRADING Sudan Ieman MOHAMMED, Eman
AGENCIES ALANE,
ISMAILIYA TRADING Irak Abdulhafidh ALANI,
AGENCIES
LABONET Guinea Djibril DIALLO, Cristelle SAWADOGO,
Guatemala Juan DE LEON, Elvis MORALES, Ricardo DE LEON, Monica CRUZ, Dorian
LABTRONIC S.A. VILLATORO, Marina CAPULA, Valeria IVANOVIC,
Fernando GALLEGOS,
Polynesia (French) Alain SUCCA, Luc FRANCK
LUC FRANCK DE FERRIERE
de FERRIERE, Bruno FAIVRE,
MAGHREB MEDICAL Tunisia Slim KHALED, Wassel AJMI, Mouhiba MOUHLI,
MAINTENANCE
Mc.Quipp Technisell Brunei Darussalam Wilson KONG, Keh Seng LIM,
Marketing Sdn. Bhd
MED‐SOLUTIONS Yemen Salah AL DEEN MANSOUR,
Cameroon (United Republic of ) Valentine NGUM, Jean‐Paul Raymond MOUDIO TIKI, Cristelle SAWADOGO,
MEDICALEX
NLEND,
Romania Ovidiu BURTEA, Madalina Carmen POPESCU,
MEDICLIM
PUSCAS,
Gabon Annicet DIKOUMBA, Marie‐Claude CHATEAU, Kokou WOUDOR, Cristelle
MEDILAB
SAWADOGO,
Kazakhstan Denis KARNAUKHOV,
MEDILAND Larissa BRAZHNIKOVA, Igor
PONAMARENKO,
Guam Chris FERAREN, Jonathan Rene RAMOS, Ramil ILAGAN,
MedPharm
ALEGRIA, Ronald ESCANO,
Slovenia Tomaz HOCEVAR, Matjaz LESNIK, Klaudia PIGEL, Simona GRANDITS, Matej
MIKRO + POLO
NOVAK,
Angola Joao LABISA, Manuela Antonio PINHEIRO, Bruno FERNANDES, Jose FERNANDES,
PERINO
AMARAL, Pedro MARTINS, Joao SOUSA, Mario WILSON,
PHARMA DISTRIBUTION Mali Amadou CISSE, Soumaïla CISSE, Yaya DIARRA, Cristelle SAWADOGO,
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Companies Countries Main addressees (to:) Copy List (cc:)
MEDICALE
Angola Pedro Rodrigues PEIXE, Morais GONCALO,
PRESTIFARMA Gregorio JUNIOR, Rui
DAVID,
Georgia Andro ATOSHVILI, Maia
MARTIASHVILI, Natia
PRIMAMEDI
SHAVDIA, Nino
BAKURADZE,
PT Enseval Putera Indonesia Sudirman SUDIRMAN, Danang SETIAWAN, Firman GEA, Lanang Sigit PRAMOJO,
Megatrading Arpri SETIYAWAN, Mia LASMIA,
Ecuador Shirley SORIA, Carlos Patricia MONTUFAR, Pablo MARCELLO, Marina CAPULA,
QUIFATEX
OLIVARES, Fernando GALLEGOS,
QUIMEXPORT‐ Angola Andrea FERRAZ,
PROQUIMICA
Peru Roxana CRUZ, Enrique Harald BRANDES, Pablo MARCELLO, Marina CAPULA,
QUIMICA SUIZA S.A.
BUSTAMANTE, Fernando GALLEGOS,
Honduras Sandra LARA DE Pablo MARCELLO, Marina CAPULA, Fernando GALLEGOS,
REPRESENTACIONES
HERNANDEZ, Rafael Nidia MADARIAGA,
MEDICAS S DE RL DE CV
MELARA,
SALVEX El Salvador Fernando GALLEGOS,
Ethiopia Alemayehu MELESSE, Seifu TEKLE MARIAM, Zelalem ANAGAW, Amsalu
SETEMA LTD PLC
TADELE, Yohanes GETU,
Shisas Trading Concern Pvt. Nepal Saras SHRESTHA,
Ltd.
SLEM MEDICAL Chad Mousbah AMBARAK,
SOPHIA SECURIS Senegal Said SAIZONOU, Georges Francois ABOUCHAR, Cristelle SAWADOGO,
SUED FARMACEUTICA C Dominican Republic Mary PEREZ, Willy Miguel VALENTIN, Marcelo BIRBRAYER, Marina
POR A. CAPULA, Fernando GALLEGOS,
Surgical Exports Bhutan Chetan LUTHRA,
Corporation
TAYLOR & TAYLOR Ghana Joe TAYLOR,
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TECNO DIAGNOSTICA QUESADA, Mario GARCIA, CAPULA, Fernando GALLEGOS,
José Pablo GONZALEZ,
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SALVADOR Fernando GALLEGOS,
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TECNOFAST S.A.
GALLEGOS,
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Sdn. Bhd. KANG YOONG, NUDDIN,
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HUANG, Reul. A PEREZ,
Inc.
Napoleon GUIANG JR.,
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TRESUL S.A.
GALLEGOS,
TUZLAFARM doo Bosnia Herzegovina Predrag MASIC, Elbisa JAHIC,
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ULTRA DIAGNOSTIC
ZEIDAN,
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VITECO
KAZAKOV,
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Copy List (Corporate sites users in copy)
Companies Copy List (cc:)
Delphine VIVERT, Patrice MOUREN, Philippe BONNET, Jean‐Paul BERLIER, Angelique MARIN, Corinne CHAPELLE, Andrew SETTE,
Aline MIGNARD, Veronique GARNIER, Veronique CUBIZOLLES, Myriam MAUHOURAT, Anne‐Sophie AUBERTY, Audrey DROGOZ,
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004045 ‐ Rev 01.A ‐ Field Action Notification Communication Forms ‐ FCA ‐ en ‐ Editable.doc
Companies Copy List (cc:)
Yann DORLIN, Sabrina DESILE, Muriel TERRIER, Christian BARRAS, Nadine FAGET, Yannick LE DROGUENE, Anne‐Marie ORJAS,
La Balme
Christian OBARA, Roland NEBOUT, Pierre‐Yves BOIS, Karine BOURNE‐BRANCHU,
Alexandre BUSTANI, Anne DESSEIGNE, Pierre LAURENT, Josiane GIRIN, Stephane DUFOIX, Yves LABAUNE, Fabienne BREJON,
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RADEMACHER, Paul TEKLINSKI,
004045 ‐ Rev 01.A ‐ Field Action Notification Communication Forms ‐ FCA ‐ en ‐ Editable.doc
Section E: Acknowledgement Form
Number: 1311 Title: FCA VITEK®2, VITEK® 2 XL and VITEK®2 Compact Instrument Connectivity Issue
Distributor Name
submitted immediately. Section 3 and 4
2. Country
should be submitted in accordance with the
3. Account # guidance in Required Actions.
4. Print
5. Position
Name
6. Sign
Name
7. Date dd / mm / yy
Product Disposition
Initial Final
16. Print
17. Position
Name
18. Sign
Name
19. Date dd / mm / yy
20. Print
21. Position
Name
22. Sign
Name
23. Date dd / mm / yy
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