BioFire recalls BCID2 Panels used with specific BD BACTEC blood culture vials, risking false Pseudomonas aeruginosa results. Affected units may need retesting or alternative vials.
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 is recalling BCID2 Panels that could give false positive results for Pseudomonas aeruginosa when used with certain BD BACTEC blood culture vials. This could lead to incorrect infection diagnoses and unnecessary treatments.
The BCID2 Panels can produce false positive results for Pseudomonas aeruginosa when paired with specific BD BACTEC blood culture vials. This could lead to incorrect infection diagnoses and unnecessary antibiotic treatments.
Healthcare professionals using BioFire BCID2 Panels with BD BACTEC vials catalog numbers 442023 or 442020 are most at risk. Patients receiving lab tests using these panels may also be affected.
Check if your BioFire BCID2 Panel has part number RFIT-ASY-0147 or unique device identifier 00815381020338. The product is used with BD BACTEC vials catalog numbers 442023 or 442020.
Verify if your BioFire BCID2 Panel is used with BD BACTEC vials catalog numbers 442023 or 442020.
The recall involves a risk of false positive results, which could lead to incorrect diagnoses but does not pose a direct risk of injury or death.
The official recall does not specify a remedy, so contact BioFire Diagnostics for guidance on retesting or alternative vials.
BD BACTEC vials catalog numbers 442023 and 442020 are affected.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-1158-2021 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-1158-2021 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.
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.
