BioMerieux recalls VITEK 2 Neisseria-Haemophilus 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 recalls VITEK 2 Neisseria-Haemophilus identification cards that may have been exposed to high temperatures during shipment. This could potentially compromise the product's ability to accurately identify bacteria, but the recall does not require immediate action for users.
The cards may have been exposed to temperatures up to 47.8°C during shipment in Guadeloupe, exceeding safe limits. This could potentially affect the cards' accuracy in identifying bacteria, but the recall does not indicate immediate health risks to users.
Users of the VITEK 2 Neisseria-Haemophilus identification cards (NH) in medical labs that received shipments from BioMerieux in Guadeloupe in 2017. Healthcare professionals using these cards for bacterial identification are most at risk if the cards were exposed to high temperatures.
Check for the VITEK 2 NH identification card (ref: 21346) with lot number 2450355203. Products were shipped to Guadeloupe in 2017 and may have been delivered to customers after quarantine.
Verify the lot number on your VITEK 2 NH identification card (ref: 21346) to see if it matches 2450355203.
No, the recall does not require immediate action. The cards may have been affected by temperature but do not pose an immediate health risk.
Check for lot number 2450355203 on the VITEK 2 NH identification card (ref: 21346) that was shipped to Guadeloupe in 2017.
The recall does not provide a remedy for affected cards. Users should check if their card has the specific lot number and contact BioMerieux if needed.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-2165-2018 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-2165-2018 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.
