Number: 2327

Title: NucliSENS© easyMAG® - Maintenance protocol reagent bottle barcodes

This MAR applies to: BOTH CLINICAL AND INDUSTRY

Catalog Profile: C55

Reference N°/ “System-Product-Service” Name : 200110/200111
Lot/Serial: N/A
Expiry date: N/A
Required Actions: See section B – Deadline: 20NOV2015

Issue Date : November 20, 2014

Section A: Details

Dear colleagues,
We would like to inform you about the availability of new barcodes used with the maintenance protocols of the
easyMAG instrument.

1. Product Distribution

Worldwide.

2. Product Description

The NucliSENS easyMAG instrument is an automated system for Nucleic Acids extraction.

Number: 2327 Title: NucliSENS© easyMAG® - Maintenance protocol reagent bottle barcodes INTERNAL USE ONLY p. 1 of 3
004045 - Rev 04.A - Field Action Notification Communication Form - MAR - en - Editable
 3. Context

In November 2009 (see GSS Info 0345), we informed you to replace the maintenance protocol reagent bottle
barcodes, included in the user’s manual, with new ones as the software will recognize the reagents as expired.
Starting end of October 2014, we ask you to use the attached reagent barcodes (see appendix 1) as the previous
ones will be identified , by the easyMAG software, as expired

Please click on the paper clip icon

4. Customer letter if needed

Please click on the paper clip icon

5. Customer communication

As a consequence, please distribute to all your customers the new barcode list and ask them to replace the page of
the user’s manual with the latest version of reagent bottle barcodes.

• For user’s manual 1.1 (ref 280139): page 7-15

• For user’s manual 2.0 (ref 280163): page 8-19

For information, the user’s manual of the easyMAG system will be updated with the new barcodes during the next
release.

If you have any additional question or doubt concerning this MAR in general, please do not hesitate to contact the
GCS through general email box :

gcs_biomol_marcy@biomerieux.com

Section B: Required actions

According to the table below:
1. Please immediately acknowledge receipt (AR) of this MAR.
2. Send the enclosed customer letter translated in your local language to all your customers using the NucliSENS easyMAG
instrument.
3. Fill the acknowledgement of completion (AC) for this MAR by 20NOV2015

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004045 - Rev 04.A - Field Action Notification Communication Form - MAR - en - Editable
 Subsidiaries using SAP
Subsidiaries not using SAP
Distributors
1) Acknowledgement of Receipt : Please immediately acknowledge receipt (AR) of this
MAR within SAP.
2) Acknowledgement of Completion :please also manage the acknowledgement of
completion within SAP.
1) Acknowledgement of Receipt : Please immediately upload the Acknowledgement of
Receipt in LiveLink after signing and completing sections #1 and #2 of the
Acknowledgement Form.
2) Acknowledgement of Completion : After completing and signing Section #3 before the
deadline, please upload the Acknowledgement of Completion in Livelink
1) Acknowledgement of Receipt : Please immediately Acknowledge of Receipt of this MAR
by completing sections #1 and #2 of the Acknowledgement Form and sending it by
email to fieldactions@biomerieux.com or by fax to +33 4 78 87 21 79.
2) Acknowledgement of Completion : After completing and signing Section #3 before the
deadline, please send it by email to fieldactions@biomerieux.com or by fax to
+33 4 78 87 21 79.

Section C: Contact Information

+ 1 919 620 33 99 + 33 4 78 87 20 80 gcs_biomol_marcy@biomerieux.com gcs.biomerieux.fr
℡ @ www

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 Section D: Acknowledgement Form

Number: 2327 Title: NucliSENS© easyMAG® - Maintenance protocol reagent Deadline: 20NOV2015
bottle barcodes

SECTION 1
Location
Group Company or Distributor Name(s) Country Account #
A
B
C
D
--------------------------------------------------------------------------------
SECTION 2
Acknowledgement of Receipt (AR)
Print Name
Sign Name
Position
Date (dd/MMM/yyyy)

--------------------------------------------------------------------------------
SECTION 3

Field Action Not Applicable

Field Action Applicable (Fill the “Acknowledgment of Completion” table below)

Acknowledgement of Completion (AC)
Group Company 1. REF # 2. LOT # 3. Total 4. Total 5. Total 6. Total 7. Total 9. Total
or Distributor Received Shipped On Hand Destroyed Instruments Updates
Affected Completed
A N.A. N.A. N.A. N.A. N.A. N.A. N.A. N.A.

Customer Letter Issue date:

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

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