Customer Service Notification

BACT/ALERT MP - SUPPLY ALLOCATION NOTIFICATION

GENERAL INFORMATION
GCS PORTAL Number 2023-424-0 CRM Number FA-007394
REVISION TABLE
Issued date Revision number Purpose of revision – short description
01-AUG-2023 Rev. 0 Creation of the document

SCOPE
Context Description: This CSN is communicating a short-term supply issue to the subsidiaries
and customers.
Product Reference(s) and Name: 419744 BACT/ALERT® MP Culture Bottle

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: 01-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: 2023-424-0 CSN title: BACT/ALERT MP - SUPPLY ALLOCATION NOTIFICATION Page 1 of 5

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

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

The benefit to share information with customers is to allow time to prepare for short-term alternate testing for
mycobacteria cultures if the BACT/ALERT MP bottles cannot be obtained.

MATERIAL REQUIRED
Material needed: ☐ Yes ✅ No ☐ Optional (in case VILINK® can be used)

CONTENT
1. Confidential information to subsidiaries:
July 2023
BACT/ALERT® Subsidiary Communication
Ref.: BMX.1.132113

We would like to notify you of a supply issue currently impacting BACT/ALERT ® MP Culture Bottle production.

The following reference is impacted due to this manufacturing issue:

References Description Market coverage
419744 BACT/ALERT MP Bottles Worldwide

The BACT/ALERT ® MP Culture Bottles are currently under allocation due to a supply issue with the MP bottle stopper. A cross
functional team has been working with the supplier to expedite the manufacturing and shipment of stoppers as well as to put
measures in place to mitigate potential supply chain interruptions in the future.

Based on communication with the supplier, we currently expect to have the next large release of MP Culture Bottles available the
week of October 9th, and back to normal inventory availability by October 23rd.

We are anticipating disruptions and/or non-availability of the above-mentioned references, and we will follow the below
action points to manage the situation:

• The impacted reference is under allocation already & we have approximately 5 weeks of stock available at the
start of July (combining all global stocks). Export shipments to subsidiaries are reviewed via weekly open order allocation.
Allocation is set by Global Marketing & Global Supply Chain & Demand based on forecast, transport, and local supply
factors. Following depletion of existing stock, we expect to be on backorder until the issue is resolved in October.

• Global Marketing and Global Supply Chain & Demand management teams will maintain close collaboration with regional
& local teams to analyze the situation, adjust the plan accordingly and share status with the concerned teams.

• For subsidiaries & regions, your primary points of contact are the following:
o James MCLEAN, Global Brand Demand & Inventory Manager
o Jennifer LAFOUNTAIN, Global Product Manager
o Alex REYNOLDS, Global Market Manager

Thank you everyone for your collaboration,

The Global Marketing & Global Supply & Demand Teams

Number: 2023-424-0 CSN title: BACT/ALERT MP - SUPPLY ALLOCATION NOTIFICATION Page 2 of 5

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)

Translate and send customer letter to all Administrative 01-SEP-2023

customers who purchase this product.

PRE-REQUISITES

N/A

ACTION(S) ON PRODUCT

N/A

OTHER (to be adjusted with the action required)

N/A

2. Further directions:

Please see the link below for the optional customer letter that may be sent to customers who receive the
BACT/ALERT MP bottles in your country. We advise you do prepare this letter through your local procedures,
translate the letter if needed, and send to the impacted customers in your country as soon as possible. You may
change the letter’s signature to your local customer service or product manager representative if desired. Please
send any questions/complaints via CRM or for non-CRM users via the GCS Portal /Support /Microbiology
Email: GCS Portal - Sharing Knowledge (biomerieux.fr)

LINKED DOCUMENTS

# Documents addressed to customers

A Customer letter

CONTACT
Support: patti.katsikis@biomerieux.com

Author: Patti Katsikis

Function: Sr Manager Blood Culture, Global Customer Service Investigation Unit

Number: 2023-424-0 CSN title: BACT/ALERT MP - SUPPLY ALLOCATION NOTIFICATION Page 3 of 5

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 BACT/ALERT MP - SUPPLY ALLOCATION NOTIFICATION

GCS PORTAL Number 2023-424-0 CRM Number: FA-007394

Overall Due Date 01-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: 2023-424-0 CSN title: BACT/ALERT MP - SUPPLY ALLOCATION NOTIFICATION Page 4 of 5

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

 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 :

SECTION 4: ACKNOWLEDGEMENT OF COMPLETION (AC)

Complete the signature box below:

Print Name

Sign Name

Position

Date (dd/MMM/yyyy)

Number: 2023-424-0 CSN title: BACT/ALERT MP - SUPPLY ALLOCATION NOTIFICATION Page 5 of 5

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