BioMerieux recalls VITEK 2 Gram Negative Susceptibility Cards due to potential temperature excursions during shipping, which could affect test accuracy in clinical labs.
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 is recalling VITEK 2 Gram Negative Susceptibility Cards that may have been exposed to high temperatures during shipping. This could lead to inaccurate test results in clinical laboratories, but the recall does not pose an immediate safety risk to users.
The cards were shipped to Guadeloupe and experienced temperature excursions up to 47.8°C, exceeding acceptable limits. This could cause the test results to be inaccurate, potentially affecting treatment decisions for bacterial infections.
Clinical laboratory users who have the VITEK 2 Gram Negative Susceptibility Cards with lot number 6330343103 are affected. Patients receiving lab results from these tests may be at risk of inaccurate treatment decisions.
Check for the lot number 6330343103 on the VITEK 2 Gram Negative Susceptibility Card. These cards were shipped to Guadeloupe in July 2017 and delivered to customers by November 2017.
Look for lot number 6330343103 on the VITEK 2 Gram Negative Susceptibility Card.
The cards may have been exposed to high temperatures during shipping, which could cause inaccurate test results in clinical laboratories.
No, the recall is for potential inaccurate test results, not a safety hazard that could cause injury.
Check for lot number 6330343103 on the VITEK 2 Gram Negative Susceptibility Card.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-2168-2018 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-2168-2018 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.
