BioFire Diagnostics recalls Gram-Negative Bacteria Blood Culture Panels that may give false Pseudomonas aeruginosa results when used with certain BD BACTEC vials. Affected units include specific model numbers and lots.
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
BioFire Diagnostics recalls its Film Array Blood Culture Identification (BCID) panels because they can produce false positive results for Pseudomonas aeruginosa when used with specific BD BACTEC blood culture vials. This could lead to incorrect infection diagnoses and inappropriate treatment.
The BCID panels may show Pseudomonas aeruginosa when it's not actually present, leading to incorrect infection diagnoses. This could cause unnecessary antibiotic treatments or delayed proper care for real infections.
Healthcare professionals using BioFire BCID panels with specific BD BACTEC vials for blood culture testing. Patients receiving treatment based on false positive results may be at risk.
Check for product model numbers RFIT-ASY-0126 or RFIT-ASY-0127 on the BCID panels. These panels were sold with BD BACTEC vials catalog numbers 442023 or 442020.
Identify if your BCID panel has model numbers RFIT-ASY-0126 or RFIT-ASY-0127.
Confirm if you're using BD BACTEC vials with catalog numbers 442023 or 442020.
No, the recall does not require immediate discontinuation. Users should check the model numbers and vial types as described.
The risk is false positive results for Pseudomonas aeruginosa, which could lead to incorrect infection diagnoses and inappropriate treatment.
Look for model numbers RFIT-ASY-0126 or RFIT-ASY-0127 on the BCID panels, which were sold with BD BACTEC vials catalog numbers 442023 or 442020.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-1157-2021 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-1157-2021 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.
