BioMerieux recalls VITEK 2 ANC identification cards shipped to Guadeloupe with temperature excursions that may affect product safety. Affected units were delivered to customers after quarantine.
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.
BioMerieux recalls VITEK 2 Anaerobic and Corynebacteria identification cards that were shipped to Guadeloupe with temperature excursions up to 47.8°C. This could potentially compromise the product's ability to accurately identify microorganisms, though no injuries have been reported.
The identification cards were shipped to Guadeloupe with temperature excursions reaching 47.8°C, which exceeds the acceptable limits. This could potentially compromise the product's ability to accurately identify microorganisms, though no injuries have been reported.
Laboratory users who purchased the VITEK 2 ANC identification card (lot 2440318203) from distributors in Guadeloupe. Those using the product for medical testing may be at risk if the temperature excursions affected its accuracy.
Check for the VITEK 2 ANC identification card (lot number 2440318203) purchased from distributors in Guadeloupe. The product is intended for use with VITEK 2 Systems for medical testing.
Verify the lot number on your VITEK 2 ANC identification card. If it is 2440318203, it may be affected.
The recall is due to temperature excursions during shipping that could affect product accuracy, but no injuries have been reported.
Check for the VITEK 2 ANC identification card with lot number 2440318203 purchased from distributors in Guadeloupe.
The official recall does not specify a remedy, so contact BioMerieux for guidance.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-2166-2018 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-2166-2018 from BioMerieux. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
