BioMerieux recalls VITEK 2 Gram Positive Susceptibility Cards due to potential temperature excursions affecting lab results. Products shipped to Guadeloupe were exposed to 47.8°C in July 2017, leading to quarantine and delayed delivery.
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 Susceptibility Cards that were shipped to Guadeloupe in July 2017. The cards may have been exposed to temperatures up to 47.8°C, which could affect lab test results. This recall affects clinical laboratory users who received these specific cards.
The cards were exposed to temperatures up to 47.8°C during shipment to Guadeloupe in July 2017, exceeding acceptable limits. This temperature excursion could potentially affect the accuracy of lab test results for bacterial susceptibility testing.
Clinical laboratory users who received the VITEK 2 Gram Positive Susceptibility Cards with lot number 4860117403 shipped to Guadeloupe in July 2017. These users are most at risk if they used the cards without confirming the temperature conditions.
Check for the VITEK 2 Gram Positive Susceptibility Card with lot number 4860117403. Products were shipped to Guadeloupe in July 2017 and may have been delivered to customers after November 2017.
Look for the lot number 4860117403 on the VITEK 2 Gram Positive Susceptibility Card.
The cards were shipped to Guadeloupe in July 2017 and experienced temperature excursions up to 47.8°C, exceeding acceptable limits.
The temperature excursion could affect the accuracy of lab test results for bacterial susceptibility testing.
Check for the lot number 4860117403 on the VITEK 2 Gram Positive Susceptibility Card, which was shipped to Guadeloupe in July 2017.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-2167-2018 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-2167-2018 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.
