Biomerieux recalls VITEK2 GP-ID ID cards due to atypical negative reactions for Enterococcus casseliflavus, risking false negative QC test results. Affected lots include specific UDI and lot numbers.
Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3) VITEK(R) 2 GP ID Lots, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. In accordance with the VITEK(R) 2 GP ID Instructions For Use, the expected O129R reaction for ATCC(R) 700327(TM) strain is positive. As a precaution, bioM¿rieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials.
Biomerieux is recalling VITEK2 GP-ID ID cards that may show false negative reactions for Enterococcus casseliflavus, which could lead to inaccurate test results. This affects specific lots and requires attention to ensure accurate diagnostic testing.
The VITEK2 GP-ID cards may produce atypical negative reactions for Enterococcus casseliflavus ATCC 700327, causing QC tests to fail. This could lead to inaccurate test results but does not pose a direct risk to users or patients.
Laboratory users who test with VITEK2 GP-ID ID cards, particularly those using the specific lot numbers mentioned. The risk is low as it only affects QC testing accuracy, not direct patient safety.
Check for the UDI 03573026131920 and Lot Number 2420348103 on the VITEK2 GP-ID ID card. The recall covers all lots manufactured with the same raw materials as these specific lots.
Look for the lot number 2420348103 on the VITEK2 GP-ID ID card.
Biomerieux found that some VITEK2 GP-ID ID cards produce atypical negative reactions for Enterococcus casseliflavus, causing QC tests to fail.
Check the lot number on your VITEK2 GP-ID ID card. If it is 2420348103, contact Biomerieux for guidance.
No, this recall only affects test accuracy and does not pose a direct risk to patients or users.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0074-2018 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0074-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
