BioMerieux recalls VITEK 2 Gram-Positive identification cards due to potential temperature excursions during shipment, which may affect product integrity. Affected units were shipped to Guadeloupe in 2017.
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-Positive identification cards that were shipped to Guadeloupe in 2017. These cards could have been exposed to temperatures up to 47.8°C during transit, potentially compromising their function for medical testing.
The cards were shipped to Guadeloupe in 2017 and experienced temperature excursions up to 47.8°C, exceeding acceptable limits. This could damage the cards' ability to properly identify bacteria, leading to inaccurate test results.
Healthcare facilities using the VITEK 2 Systems for medical testing in Guadeloupe may be affected. Patients relying on these cards for accurate bacterial identification could face potential risks if the cards are compromised.
Check for the VITEK 2 Gram-Positive identification card (GP) with lot number 2420352403. Products were shipped to Guadeloupe in 2017 and may have been delivered to customers after quarantine.
Look for the lot number 2420352403 on the VITEK 2 GP identification card.
The cards were shipped to Guadeloupe in 2017 and experienced temperature excursions up to 47.8°C, which could compromise their function for medical testing.
Check for the VITEK 2 Gram-Positive identification card (GP) with lot number 2420352403. Products were shipped to Guadeloupe in 2017 and may have been delivered to customers after quarantine.
The recall record does not specify any action steps for affected products.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-2164-2018 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-2164-2018 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.
