BioMerieux SA: 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.

Agency Publication Date: June 12, 2018

Affected Products

Product: 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

VITEK¿ 2 GP (ref: 21342):Lot Number 2420352403

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Product: 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

VITEK 2 NH (ref: 21346): Lot Number 2450355203

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Product: 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 p

VITEK¿ 2 ANC (ref: 21347): Lot Number 2440318203

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Product: 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

VITEK¿ 2 AST-P606 (ref: 22330): Lot Number 4860117403

Lot Numbers:

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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 isolat

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

Lot Numbers:

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Product: 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 anti

VIDAS¿ TOXO IgG AVIDITY (ref: 30222): Lot Number 1005621420

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Product: 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.

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

Lot Numbers:

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Number

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Product: 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

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Product: 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 i

Oxidase Reagent (ref: 55635): Lot number 92366601

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80111

Status: Resolved

Manufacturer: BioMerieux SA

Manufactured In: France

Units Affected: 9 products (15 boxes with GP TEST KIT VTK2 20 CARDS; 2 boxes of NH TEST KIT with 20 Cards; 135 (78 boxes of various product) in total; 5 boxes with AST-P606 TEST KIT 20 CARDS; 135 (78 boxes of various product) in total; 2 boxes VIDAS TOXO IGG AVIDITY 30 TESTS; FUCHSIN-A (ref: 29522) 15 eaches; IODINE-B (ref: 29523) 10 eaches ; CRYSTAL VIOLET-C (ref: 29524) 10 eaches; 8 boxes COLOR GRAM2 with 4 - 240ML bottles in each; 4 boxes of OXIDASE REAGENT with 50 - 0.75ML bottles)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

VITEK¿ 2 GP (ref: 21342):Lot Number 2420352403

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Number

VITEK 2 NH (ref: 21346): Lot Number 2450355203

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Number

VITEK¿ 2 ANC (ref: 21347): Lot Number 2440318203

Lot Numbers:

Number

VITEK¿ 2 AST-P606 (ref: 22330): Lot Number 4860117403

Lot Numbers:

Number

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

Lot Numbers:

Number

VIDAS¿ TOXO IgG AVIDITY (ref: 30222): Lot Number 1005621420

Lot Numbers:

Number

Lot Numbers:

number

Number

number

Color Gram 2 (COLOR GRAM 2 - F) (ref: 55542) Lot number G64508

Lot Numbers:

number

Oxidase Reagent (ref: 55635): Lot number 92366601

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80111

Status: Resolved

Manufacturer: BioMerieux SA

Manufactured In: France