BioMerieux recalls VIDAS TOXO IgG Avidity tests due to temperature excursions in shipments to Guadeloupe, potentially affecting product safety.
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 VIDAS TOXO IgG Avidity tests that were shipped to Guadeloupe and experienced temperature excursions up to 47.8°C. This could affect the test's accuracy and safety, but the recall does not specify a direct risk to users.
The tests were shipped to Guadeloupe and experienced temperature excursions up to 47.8°C, which exceeded acceptable limits. This could potentially compromise the test's accuracy and safety, but the recall does not specify a direct risk to users.
Users of VIDAS TOXO IgG Avidity tests in Guadeloupe may be affected. The recall targets specific shipments that were delivered to customers after being quarantined.
Check for the VIDAS TOXO IgG Avidity test with lot number 1005621420. The product was shipped to Guadeloupe and experienced temperature excursions.
Identify if you have the VIDAS TOXO IgG Avidity test with lot number 1005621420.
The tests were shipped to Guadeloupe and experienced temperature excursions up to 47.8°C, exceeding acceptable limits.
The recall does not specify a direct risk to users, but the temperature excursions could affect the test's accuracy and safety.
Check for the VIDAS TOXO IgG Avidity test with lot number 1005621420.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-2169-2018 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-2169-2018 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.
