Biomerieux recalls two batches of VIDAS Varic: Zoster IgG antibody kits due to potential invalid calibration causing delayed results or false positives. Affected kits include US Model 30217-01 Lot 1007410330 and 1007393380.
Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result.
Biomerieux is recalling two specific batches of VIDAS Varicella-Zoster IgG antibody kits because they might give incorrect test results. This could delay patient care or cause false positives, which is serious for medical testing.
The kits may have calibration issues that cause test results to be delayed or inaccurate. This could lead to false positive results, meaning a person might be incorrectly diagnosed with a condition they don't have.
People who own or use the recalled kits for medical testing are affected. Those with the specific model and lot numbers listed are most at risk.
Check the product label for US Model 30217-01 and lot numbers 1007410330 or 1007393380. The kits are used for medical testing of varicella-zoster virus antibodies.
Look for US Model 30217-01 and lot numbers 1007410330 or 1007393380 on the product label.
The recall is due to potential invalid calibration in two batches of kits, which could delay patient results or cause false positive results.
The official notice does not specify a remedy, so check the product label to see if you have the affected model and lot numbers.
The recall indicates a risk of delayed results or false positives, which could affect medical diagnosis, but the remedy is not specified.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-1107-2020 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-1107-2020 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.
