Customer Service Notification

ETEST® - PACKAGING & DOCUMENTATION

TRANSFORMATION - CONTINUATION
GENERAL INFORMATION
GCS PORTAL Number 2023-306-2 CRM Number (If FA-007393
applicable):
REVISION TABLE
Issued date Revision number Purpose of revision – short description
31-MAY-2023 Rev 0 Creation of the document
29-JUN-2023 Rev. 1 Clarification on the ETEST reference numbers that
should be tracked in CRM. The section ‘Scope’ now
contains the old references to be tracked in CRM.
References are old references and not new ones.
02-AUG-2023 Rev. 2 This CSN cancels and replaces CSN 2023-306-1

Removal of ETEST® MBL - Imipenem/Imipenem + EDTA

from WW and USA table.

Re insertion of information of I.F.U FOR ETEST®

Piperacillin (PP). Missing from rev 1.

SCOPE
Context Description:
A. Launch of 5 Single Pack references replacing Blister B30 & B100 packaging
B. Single IFU implemented to 7 additional Single Pack (S30) references
(different references for World-wide and USA only)

Product Reference(s) and Name: References to be tracked in CRM

Part A. PRODUCTS TO BE CRM TRACKED

WORLD WIDE (EXCLUDING USA)

B30/B100 references
Brand Name
discontinued
532200 (B30)
ETEST® ESBL Cefotaxime/cefotaxime + clavulanic acid (CT/CTL)
532208 (B100)
532500 (B30)
ETEST® ESBL Ceftazidime/ceftazidime + clavulanic acid (TZ/TZL)
532508 (B100)
534700 (B30)
ETEST® ESBL Cefepime/cefepime + clavulanic acid (PM/PML)
534708 (B100)
ETEST® MBL Meropenem/Meropenem + EDTA (MP/MPI) 411361 (B30)
537100 (B30)
ETEST® AmpC Cefotetan/Cefotetan + Cloxacillin (CN/CNI) - RUO
537108 (B100)

Number: 2023-306-2 CSN TITLE: ETEST® – PACKAGING & DOCUMENTATION TRANSFORMATION – CONTINUATION Page 1 of 6

Confidential Information Created from Template 026345 - Attachment 2 - Rev 06.A

USA ONLY
B30/B100 references
Brand Name
discontinued

532240 (B30)
ETEST® ESBL Cefotaxime/cefotaxime + clavulanic acid (CT/CTL)
532248 (B100)

532540 (B30)
ETEST® ESBL Ceftazidime/ceftazidime + clavulanic acid (TZ/TZL)
532548 (B100)
534740 (B30)
ETEST® ESBL Cefepime/cefepime + clavulanic acid (PM/PML) - RUO
534748 (B100)
ETEST® MBL Meropenem/Meropenem + EDTA (MP/MPI) - RUO 411363 (B30)

ETEST® AmpC Cefotetan/Cefotetan + Cloxacillin (CN/CNI) - RUO 537140 (B30)

Market: ✅ 10- Clinical (Clinical, Veterinary) ☐ 20- POL (= Physician Office Laboratory)
☐ 40 Food (Industry Food ) ☐ 60- Healthcare (Industry Pharma, Blood bank)

Impacted country(ies): All subs and distributors commercializing these references.

Target date: 02 SEP 2023

ACTIONS
Actions required

☐ No for information only

✅ Yes: Actions required

✅ Action at subsidiary/distributor level
☐ Action at customer level: ☐ bioMérieux staff FSE/FAS/FIT action required at customer site
☐ Action Doable remotely (eg VILINK® , Remote Video Service (RVS) or other tools)
☐ Doable / To be done by the customer

☐ Deployment follow-up needed

Number: 2023-306-2 CSN TITLE: ETEST® – PACKAGING & DOCUMENTATION TRANSFORMATION – CONTINUATION Page 2 of 6

Confidential Information Created from Template 026345 - Attachment 2 - Rev 06.A

ACTIONS DETAILS
INITIAL CUSTOMER NOTIFICATION

Description Impacted function Target date

(to be adjusted according to your
local organization)

Identify and translate the Customer Letter into Administrative 02 SEP 2023
local language.

IMPACT
Added value to perform action(s)

Updating user on ETEST packaging and IFU updates.

CONTENT
WORLD WIDE (EXCLUDING USA)
PART A:
5 ETEST references are newly available in Single Pack (S30) packaging to replace Blister B30 & B100
references

New B30/B100
Concentration
Brand Name Single Pack S30 references
(µg/mL)
references discontinued
ETEST® ESBL 0.25-16/0.016-1 532200 (B30)
423994
Cefotaxime/cefotaxime + clavulanic acid (CT/CTL) +Clavulanic Acid: 4 532208 (B100)
ETEST® ESBL 0.5-32/0.064-4 532500 (B30)
423992
Ceftazidime/ceftazidime + clavulanic acid (TZ/TZL) +Clavulanic Acid: 4 532508 (B100)
ETEST® ESBL 0.25-16/0.064-4 534700 (B30)
423996
Cefepime/cefepime + clavulanic acid (PM/PML) +Clavulanic Acid: 4 534708 (B100)
ETEST® MBL 0.125-8/0.032-2
424020 411361 (B30)
Meropenem/Meropenem + EDTA (MP/MPI) EDTA: 320

ETEST® AmpC 0.5-32/0.5-32 537100 (B30)

424026
Cefotetan/Cefotetan + Cloxacillin (CN/CNI) - RUO Cloxacillin: 100 537108 (B100)

PART B: 7 ETEST Single Pack references newly linked to single IFU

Reference
Brand Name Packaging References
status

ETEST® Caspofungin (CS) Single Pack (S30) 412269 Existing reference

ETEST® Piperacillin (PP) Single Pack (S30) 412436 Existing reference
ETEST® ESBL (CT/CTL) Single Pack (S30) 423994 New reference
ETEST® ESBL (TZ/TZL) Single Pack (S30) 423992 New reference
ETEST® ESBL (PM/PML) Single Pack (S30) 423996 New reference
ETEST® MBL (MP/MPI) Single Pack (S30) 424020 New reference
ETEST® AmpC (CN/CNI) Single Pack (S30) 424026 New reference

Number: 2023-306-2 CSN TITLE: ETEST® – PACKAGING & DOCUMENTATION TRANSFORMATION – CONTINUATION Page 3 of 6

Confidential Information Created from Template 026345 - Attachment 2 - Rev 06.A

 USA ONLY
PART A: 5 ETEST references are newly available in Single Pack (30) and will replace the associated Blister
(B30 and B100) references once out of stock.

New
B30/B100
Concentration Single Pack
Brand Name references
(µg/mL) S30
discontinued
references
ETEST® ESBL 0.25-16/0.016-1 532240 (B30)
423995
Cefotaxime/cefotaxime + clavulanic acid (CT/CTL) +Clavulanic Acid: 4 532248 (B100)

ETEST® ESBL 0.5-32/0.064-4 532540 (B30)

423993
Ceftazidime/ceftazidime + clavulanic acid (TZ/TZL) +Clavulanic Acid: 4
532548 (B100)

ETEST® ESBL 0.25-16/0.064-4 534740 (B30)

423997
Cefepime/cefepime + clavulanic acid (PM/PML) - RUO +Clavulanic Acid: 4 534748 (B100)
ETEST® MBL 0.125-8/0.032-2 424021 411363 (B30)
Meropenem/Meropenem + EDTA (MP/MPI) - RUO EDTA: 320

ETEST® AmpC 0.5-32/0.5-32 537140 (B30)

424027
Cefotetan/Cefotetan + Cloxacillin (CN/CNI) - RUO Cloxacillin: 100

PART B: 7 ETEST Single Pack references newly linked to single IFU

Reference
Brand Name Packaging References
status

ETEST® Caspofungin (CS) Single Pack (S30) 412268 Existing reference

ETEST® Piperacillin (PP) Single Pack (S30) 412435 Existing reference
ETEST® ESBL (CT/CTL) Single Pack (S30) 423995 New reference
ETEST® ESBL (TZ/TZL) Single Pack (S30) 423993 New reference
ETEST® ESBL (PM/PML) Single Pack (S30) 423997 New reference
ETEST® MBL (MP/MPI) Single Pack (S30) 424021 New reference
ETEST® AmpC (CN/CNI) Single Pack (S30) 424027 New reference

LINKED DOCUMENTS

# Documents addressed to customers

A Customer letter (World-wide excluding USA)

B Customer letter (USA only)

CONTACT
Support: gabriella.petrera@biomerieux.com

Author: GABRIELLA PETRERA

Function: APPLICATION SPECIALIST – MICRO EXPERT UNIT GCS

Number: 2023-306-2 CSN TITLE: ETEST® – PACKAGING & DOCUMENTATION TRANSFORMATION – CONTINUATION Page 4 of 6

Confidential Information Created from Template 026345 - Attachment 2 - Rev 06.A

 ACKNOWLEDGEMENT FORM (if applicable, for subsidiaries,
plants and export distributors outside CRM)
Applicable: Yes � / No ☐
Yes (CSN managed in CRM) // If No, you can skip the following sections

GENERAL INFORMATION
CSN Title ETEST® - Packaging & Documentation Transformation – continuation

GCS PORTAL Number 2023-306-2 CRM Number: FA-007393

Overall Due Date 02 SEP 2023
(Target Date)

SECTION 1: LOCATION
Group Company or Distributor Name(s) Country Account #

SECTION 2: ACKNOWLEDGEMENT OF RECEIPT (AR)

Print Name
Sign Name
Position
Date (dd/MMM/yyyy)

SECTION 3: ACTIONS REQUIRED (service tasks)

Check the appropriate box and follow the instructions for completion.
CSN Not Applicable: Provide justification for each sections A, B and C
Complete the signature box below in section D and return
form.

CSN Applicable: Complete the following sections A, B C.

Complete the signature box below and return form in
section D
3.A – Initial Notification to Customer

If Not Applicable: Provide justification: …………………………………………………………………………………

…………………………………………………………………………………………………………………..

if Applicable: Complete the information of the ‘’Initial Notification to Customer’’ in the space
below:

COMPLETION DATE (customer letter issue date): dd/MMM/yyyy

3.B – Actions on Products

If Not Applicable: Provide justification: …………………………………………………………………………………

…………………………………………………………………………………………………………………..

if Applicable: Complete the required information of the ‘’Actions on Product’’ in the space
below:

Number: 2023-306-2 CSN TITLE: ETEST® – PACKAGING & DOCUMENTATION TRANSFORMATION – CONTINUATION Page 5 of 6

Confidential Information Created from Template 026345 - Attachment 2 - Rev 06.A

 Action(s) on Product

Actions # Completion Date

3.C– CHECKING PRE-REQUISITES

If Not Applicable: Provide justification: …………………………………………………………………………………

………………………………………………………………………………………………………………….
Complete the space below for ‘’the checking of the pre requisites’’ mentioned in
if Applicable: the CSN:

COMPLETION DATE : dd/MMM/yyyy

3.D– Other (if applicable)

If Not Applicable: Provide justification: …………………………………………………………………………………

………………………………………………………………………………………………………………….

if Applicable: Complete the following :

Other

Other # Completion Date

SECTION 4: ACKNOWLEDGEMENT OF COMPLETION (AC)

Complete the signature box below:

Print Name

Sign Name

Position

Date (dd/MMM/yyyy)

Number: 2023-306-2 CSN TITLE: ETEST® – PACKAGING & DOCUMENTATION TRANSFORMATION – CONTINUATION Page 6 of 6

Confidential Information Created from Template 026345 - Attachment 2 - Rev 06.A