Z-2168-2018Class II

The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical...

Name: Z-2168-2018 The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical...
Creator: BioMerieux SA
Published: 2018-03-23
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2018-03-23 / Terminated / root cause: manufacturing process

FDA source

BioMerieux SA began a recall of The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the... on 2018-03-23. FDA classified it as Class II and gives the reason as "A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMrieux distributor in Guadeloupe to put products...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2168-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-23
Posted: 2018-06-12
Terminated: 2020-06-23
Recalling firm: bioMerieux, Inc.
Product: The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram negative bacilli to antimicrobial agents. Fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMrieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: The firm, Biomerieux, sent an "Urgent product removal notice" letter on April 23 to affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately acknowledge receipt (AR) of this FSCA. 2. Identify all countries and customers for which you are responsible that are impacted by this FSCA. 3. Define additional actions required (e.g. Translate customer letter, send to impacted countries/customers, etc.) 4. Distribute the customer letter to all customers that have received the products 5. Discard any impacted product remaining in local inventory 6. After all actions above are complete, please return the acknowledgement of completion (AC) for this FSCA. The due date for completion of the required actions and submitting the AC is 23-APR-2018 Subsidiaries Subsidiaries using SAP, please manage both the Acknowledgment of Receipt and the Acknowledgment of Completion of activities in SAP. Subsidiaries not using SAP, please immediately upload the Acknowledgement of Receipt in LiveLink after signing and completing sections #1 and #2. Section #3 must be signed, completed and uploaded in LiveLink before the due date. Distributors Please immediately Acknowledge Receipt of this FSCA by completing sections #1 and #2 of the acknowledgement form and sending it by email to [email protected] or by fax to +33 4 78 87 21 79. Please remember to sign and complete all of sections #1 and #2. Sections #1 and #3 must be signed, completed, faxed or emailed before the due date. If you have any questions, contact the Specialist, Regulatory & Quality Compliance at +33 4 78 87 56 16 or email to: [email protected].
Quantity in commerce: 135 (78 boxes of various product) in total
Distribution: International distribution.
Product codes and lots: VITEK¿ 2 AST-N233 (ref: 413117): Lot Number 6330343103

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2168-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2164-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2165-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2166-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2167-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2168-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2169-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2170-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2171-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2172-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12

Product code LON

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)