CLASS II Device recall · Reported 20 Jun 2018 · FDA Enforcement Report

The Vitek Negative Susceptibility Card is intended recalled

BioMerieux is recalling The Vitek Negative Susceptibility Card is intended for use with the Vitek 2 Systems in. The recall was initiated on 23 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVITEK¿ 2 AST-N233 (ref: 413117): Lot Number 6330343103

Quantity recalled135 (78 boxes of various product) in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2168-2018
FDA event ID: 80111
Recalling firm: BioMerieux, Marcy L'Etoile, N/A
Classification: Class II
Status: Terminated
Recall initiated: 23 Mar 2018
FDA classified: 12 Jun 2018
Reported: 20 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Test Kits & Diagnostics

Timeline

23 Mar 2018	Recall initiated by company
12 Jun 2018	Classified by FDA	+81 days
20 Jun 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux 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.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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.

Where it was distributed

International distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

VITEK¿ 2 AST-N233 (ref: 413117): Lot Number 6330343103

Where was it sold?

International distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 80111

This product is part of a recall event; the main page for the event is The Vitek¿ Positive Susceptibility Card is intended recalled.

Reported	Class	Recall	Company	Reason	Where
20 Jun 2018	CLASS II	The Vitek¿ Positive Susceptibility Card is intended recalled	BioMerieux	Temperature Abuse	N/A
20 Jun 2018	CLASS II	The Vitek¿ 2 Anaerobic and Corynebacteria identification recalled	BioMerieux	Temperature Abuse	N/A
20 Jun 2018	CLASS II	Vidas Toxo IgG Avidity is an automated qualitative test recalled	BioMerieux	Temperature Abuse	N/A
20 Jun 2018	CLASS II	The Vitek-Positive identification card (GP) is intended recalled	BioMerieux	Temperature Abuse	N/A
20 Jun 2018	CLASS II	The Vitek 2 Neisseria-Haemophilus identification card recalled	BioMerieux	Temperature Abuse	N/A
20 Jun 2018	CLASS II	Oxidase Reagent recalled by BioMerieux	BioMerieux	Temperature Abuse	N/A
20 Jun 2018	CLASS II	The Previ¿ Color Gram dyes are used recalled by BioMerieux	BioMerieux	Temperature Abuse	N/A
20 Jun 2018	CLASS II	Color Gram 2 (Color Gram 2 - F) recalled by BioMerieux	BioMerieux	Temperature Abuse	N/A

More recalls from BioMerieux

All 476

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux	Biomerieux	Other	MO
11 Feb 2026Device	CLASS II	Vitek-negative Susceptibility Cards Containing o Polymyxin recalled	Biomerieux	Sterility	Nationwide
8 Oct 2025Device	CLASS II	Vitek¿-negative AST Test Kits (Cards) recalled by bioMerieux	bioMerieux	Sterility	NC
1 May 2024Device	CLASS I	Vitek 2 - AST Test kits (in vitro diagnostic test cards recalled	Biomerieux	Other	MO
8 Mar 2023Device	CLASS II	Myla comprises Ast Filters in conjunction with Vitek MS recalled	Biomerieux	Other	Nationwide

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All 2,656

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26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
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