BioFire recalls BCID2 blood culture panels with possible false Acinetobacter calcoaceticus-baumannii complex results due to non-viable contamination in vials. Affected panels expire by April 30, 2022.
Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials.
BioFire Diagnostics recalls certain blood culture identification panels that may give false positive results for Acinetobacter calcoaceticus-baumannii complex. This could lead to incorrect infection diagnoses if used in medical settings.
The panels may produce false positive results for Acinetobacter calcoaceticus-baumannii complex due to non-viable contamination in the blood culture vials. This could lead to incorrect infection diagnoses if the panels are used in medical testing.
Healthcare facilities using the recalled blood culture panels are most at risk. Patients receiving blood cultures with these panels could potentially receive incorrect infection diagnoses.
Check for BioFire BCID2 Panel Part No: RFIT-ASY-0147 with UDI code 00815381020338. The panels expire by April 30, 2022 or earlier.
Verify the expiration date on the panel vials; affected units expire by April 30, 2022.
The recall is due to an increased risk of false positive Acinetobacter calcoaceticus-baumannii complex results caused by non-viable contamination in the blood culture vials.
The official recall notice does not specify action steps for healthcare facilities beyond checking the expiry date.
The recall indicates a potential for incorrect infection diagnoses, but the official notice does not specify patient safety risks.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-0312-2022 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-0312-2022 from BioFire. 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.