Customer Service Notification

VITEK® 2 - AST Cards eIFU Availability

GENERAL INFORMATION
GCS PORTAL Number 2023-431-0 CRM Number (If N/A
applicable):
REVISION TABLE
Issued date Revision number Purpose of revision – short description
31-JUL-2023 Rev. 0 Creation of the document

SCOPE
Context Description: VITEK® 2 AST package inserts have been updated to the new eIFU format
Product Reference(s) and Name: See table in Content section

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

Impacted country(ies): WorldWide

Target date: N/A

ACTIONS
Actions required

No for information only

INSTALLED BASE UPDATE

N/A

IMPACT
Added value to perform action(s)
N/A

MATERIAL REQUIRED
Material needed: ☐ Yes ✅ No

Number: 2023-431-0 CSN title: VITEK® 2 - AST Cards eIFU Availability Page 1 of 4

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

 CONTENT
AST Package inserts are being updated to the new eIFU format (extended Instructions For Use) which includes all
relevant information from the product information manual, as well as the traditional information that was already
present in the package insert.

A list of cards impacted by the package insert update has been provided below.

REF# Description
413399 AST-GN67
420597 AST-N346
421351 AST-N355

This extended package insert is already or soon to be available on the Resource Center. There is no need for
communication to the customer. This notification is simply to alert you to the changes taking place for cards that
are currently being utilized. Customer communication is accomplished via the green leaflet printed on the inside
flap of the carton alerting the customer to print a new copy of the updated package insert via the Resource Center.

CONTACT
Support: jenny.overman@biomerieux.com
Author: Jenny Overman
Function: Global Customer Service | Investigation Unit Operational Manager- VITEK 2 ®

Number: 2023-431-0 CSN title: VITEK® 2 - AST Cards eIFU Availability Page 2 of 4

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
GCS PORTAL Number CRM Number:
Overall Due Date
(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: 2023-431-0 CSN title: VITEK® 2 - AST Cards eIFU Availability Page 3 of 4

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: 2023-431-0 CSN title: VITEK® 2 - AST Cards eIFU Availability Page 4 of 4

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