BioFire recalls BCID2 Blood Culture Panel for FILMARRAY Systems when used with specific culture media lots. False positive Serratia marcescens results may lead to incorrect patient treatment.
If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.
BioFire is recalling its BCID2 Blood Culture Identification Panel for FILMARRAY Systems. Using this panel with certain culture media bottles can cause false positive results for Serratia marcescens, which might lead to inappropriate patient treatment.
The panel can produce false positive results for Serratia marcescens when used with specific lots of culture media bottles. This false positive might lead to unnecessary changes in patient therapy, but does not cause immediate harm or injury.
Healthcare facilities using BioFire BCID2 panels with specific culture media lots (BACT/ALERT FA PLUS or PF PLUS) are affected. Patients receiving blood culture tests with these panels may be at risk of incorrect treatment.
Check if your BCID2 panel has the reference number RFIT-ASY-0147 and is used with BACT/ALERT FA PLUS (REF: 410851) or PF PLUS (REF: 410853) culture media bottles. The affected media lots have specific expiration dates listed in the recall notice.
Verify your BCID2 panel reference number is RFIT-ASY-0147 and that you're using specific culture media lots listed in the recall notice.
Using the BCID2 panel with certain culture media lots can cause false positive results for Serratia marcescens, which might lead to inappropriate patient treatment.
BACT/ALERT FA PLUS (REF: 410851) and BACT/ALERT PF PLUS (REF: 410853) culture media bottles with specific lots listed in the recall notice.
No, but you should check if your panel and media lots are affected before using them. The recall does not require immediate discontinuation.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-2456-2024 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-2456-2024 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.
