Lower risk Medical device recall · FDA · Published March 23, 2018

BioMerieux VITEK 2 Gram Positive Card Recall: Temperature Risk

BioMerieux recalls VITEK 2 Gram Positive Susceptibility Cards due to potential temperature excursions affecting lab results. Products shipped to Guadeloupe were exposed to 47.8°C in July 2017, leading to quarantine and delayed delivery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2167-2018Medical device BioMerieux ›

Lower-risk 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.

Take action

Contact the company

Recalling firmBioMerieux SAChemin De L'Orme · Marcy L'Etoile, France

✎ GovInfoNow plain-language explainer

BioMerieux is recalling VITEK 2 Gram Positive Susceptibility Cards that were shipped to Guadeloupe in July 2017. The cards may have been exposed to temperatures up to 47.8°C, which could affect lab test results. This recall affects clinical laboratory users who received these specific cards. Read more at govinfonow.com/recall/71635-biomerieux-vitek-2-gram-positive-card-recall-temperature-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71635-biomerieux-vitek-2-gram-positive-card-recall-temperature-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2167-2018

Cite this page

“BioMerieux VITEK 2 Gram Positive Card Recall: Temperature Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71635-biomerieux-vitek-2-gram-positive-card-recall-temperature-risk. Based on FDA recall #Z-2167-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2167-2018%22&limit=1).

The Food and Drug Administration announced on March 23, 2018, that BioMerieux SA voluntarily recalled The VITEK¿ 2 Gram Positive Susceptibility Card due to temperature excursions exceeding acceptable limits. According to the FDA, the hazard involves potential product degradation from heat exposure.

How to tell if you have it

Brand: BioMerieux
Product: The VITEK¿ 2 Gram Positive Susceptibility Card
Model/Kit: VITEK¿ 2 AST-P606 (ref: 22330)
Lot Number: 4860117403

The hazard

A shipment to Guadeloupe suffered temperature excursions up to 47.8¿C, exceeding 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.

Context

GovInfoNow's records show BioMerieux SA has 5 other recalls on record since 2017-10-18. Other recent recalls of similar products include Biomerieux VITEK 2 Gram-negative Susceptibility Cards May Give False Antibiotic Results (2026-01-05), Biomerieux VITEK 2 AST-N461 Test Kit Recall: False Resistant Results Risk (2026-07-24), and Biomerieux VITEK 2 AST-N447 Kit Recall: False Resistance Results Risk (2026-06-04).

How to tell if you have this one

Check for the VITEK 2 Gram Positive Susceptibility Card with lot number 4860117403. Products were shipped to Guadeloupe in July 2017 and may have been delivered to customers after November 2017.

Brand
BioMerieux
Category
Medical device

FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
International distribution.

Recall number	Product, codes & lots	Quantity
Z-2164-2018	The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single-use disposable. GP TEST KIT VTK2 20 CARTES A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms.; VITEK¿ 2 GP (ref: 21342):Lot Number 2420352403	15 boxes with GP TEST KIT VTK2 20 CARDS
Z-2165-2018	The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.; VITEK 2 NH (ref: 21346): Lot Number 2450355203	2 boxes of NH TEST KIT with 20 Cards
Z-2166-2018	The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK¿ 2 ANC identification card is a single-use disposable. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.; VITEK¿ 2 ANC (ref: 21347): Lot Number 2440318203	135 (78 boxes of various product) in total
Z-2167-2018	The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae 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.; VITEK¿ 2 AST-P606 (ref: 22330): Lot Number 4860117403	5 boxes with AST-P606 TEST KIT 20 CARDS
Z-2168-2018	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.; VITEK¿ 2 AST-N233 (ref: 413117): Lot Number 6330343103	135 (78 boxes of various product) in total
Z-2169-2018	VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens.; VIDAS¿ TOXO IgG AVIDITY (ref: 30222): Lot Number 1005621420	2 boxes VIDAS TOXO IGG AVIDITY 30 TESTS
Z-2170-2018	The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have been smeared with specimens to be examined. The staining procedure is rapid and precise. Each reagent has a specific position (A, B, C, D, E) on the PREVI¿ Color Gram platform that is also indicated on the reagent label. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.; Reagents for use with the PREVI¿ Color Gram: IODINE-B (ref: 29523) Lot number: G59407 Exp. 15-Aug-18 CRYSTAL VIOLET-C (ref: 29524) Lot number: G52306 Exp.19-Jul-18 FUCHSIN-A (ref: 29522): Lot Number Lot number: F89544 Exp. 13-Apr-18	FUCHSIN-A (ref: 29522) 15 eaches; IODINE-B (ref: 29523) 10 eaches ; CRYSTAL VIOLET-C (ref: 29524) 10 eaches
Z-2171-2018	Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.; Color Gram 2 (COLOR GRAM 2 - F) (ref: 55542) Lot number G64508	8 boxes COLOR GRAM2 with 4 - 240ML bottles in each
Z-2172-2018	Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria. This enzyme is characteristic of the genus Neisseria and most species of Pseudomonas. It enables the differentiation of Gram (-) bacilli (1, 2). A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.; Oxidase Reagent (ref: 55635): Lot number 92366601	4 boxes of OXIDASE REAGENT with 50 - 0.75ML bottles

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot number 4860117403 on the VITEK 2 Gram Positive Susceptibility Card.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

Mar 23, 2018Firm started the recall
Jun 12, 2018FDA classified it Class II
Jun 20, 2018Published in FDA’s Enforcement Report
Jun 23, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More BioMerieux recalls

Link to this recall

<a href="https://govinfonow.com/recall/71635-biomerieux-vitek-2-gram-positive-card-recall-temperature-risk">BioMerieux VITEK 2 Gram Positive Card Recall: Temperature Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2167-2018 (March 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2167-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.