FDA (Devices) recall action 80111

BioMerieux SA recalled 9 products on 2018-06-20

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2018-06-20
Critical: 0
Units: —

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

1–9 of 9

ModerateFDA (Devices)··2018-06-20
BioMérieux Recalls VITEK 2 Gram-Positive Cards Due to Temperature Excursion
BioMérieux is recalling VITEK 2 Gram-Positive identification cards in Guadeloupe because a shipment experienced a temperature excursion exceeding acceptable limits.
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 microorga
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0 states
ModerateFDA (Devices)··2018-06-20
BioMérieux PREVI Color Gram Reagents Recalled Due to Temperature Excursion
BioMérieux is recalling PREVI Color Gram reagents shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.
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 b
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ModerateFDA (Devices)··2018-06-20
BioMérieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Temperature Excursion
BioMérieux is recalling VITEK 2 Gram Negative Susceptibility Cards shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.
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
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ModerateFDA (Devices)··2018-06-20
BioMérieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Temperature Excursion
BioMérieux is recalling VITEK 2 Gram Positive Susceptibility Cards in Guadeloupe because a shipment experienced a temperature excursion up to 47.8°C, exceeding acceptable limits.
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
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ModerateFDA (Devices)··2018-06-20
BioMérieux Recalls Color Gram 2 Stains Due to Temperature Excursion
BioMérieux is recalling Color Gram 2 stains in Guadeloupe after a shipment experienced a temperature excursion exceeding acceptable limits.
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 sol
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ModerateFDA (Devices)··2018-06-20
BioMérieux Recalls Oxidase Reagent Due to Temperature Excursion in Guadeloupe
BioMérieux is recalling Oxidase Reagent (ref: 55635) in Guadeloupe after a shipment experienced temperature excursions up to 47.8°C, exceeding acceptable limits.
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 microorgan
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ModerateFDA (Devices)··2018-06-20
BioMerieux VITEK 2 ANC Card Recalled Due to Temperature Excursion
BioMerieux is recalling VITEK 2 ANC identification cards shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.
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
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ModerateFDA (Devices)··2018-06-20
BioMérieux Recalls VIDAS TOXO IgG Avidity Test Due to Temperature Excursion
BioMérieux is recalling VIDAS TOXO IgG Avidity tests because a shipment to Guadeloupe exceeded temperature limits. The products were delivered to customers despite quarantine instructions.
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). T
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ModerateFDA (Devices)··2018-06-20
BioMérieux Recalls VITEK 2 NH Cards Due to Temperature Excursion
BioMérieux is recalling VITEK 2 Neisseria-Haemophilus identification cards in Guadeloupe that were exposed to temperatures exceeding acceptable limits.
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 differe
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