BioFire Diagnostics recalls FilmArray Blood Culture Identification kits that may give false positive results for Proteus when used with certain blood culture bottles. Affected kits include specific catalog numbers and bottle types.
Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.
BioFire Diagnostics is recalling some FilmArray Blood Culture Identification kits because they can produce false positive results for Proteus when used with specific blood culture bottles. This could lead to incorrect diagnoses and unnecessary treatments.
The FilmArray kits can give false positive results for Proteus bacteria when used with specific blood culture bottles (BACT/ALERT FA Plus, FN Plus, or PF Plus). This means tests might incorrectly indicate Proteus infection when there isn't one, potentially leading to unnecessary treatments.
Healthcare facilities using the recalled FilmArray Blood Culture Identification kits with the listed blood culture bottles are most at risk. Patients receiving blood cultures with these kits may be affected if the false positive results lead to incorrect treatment.
Check if your FilmArray Blood Culture Identification kit has catalog numbers RFIT-ASY-0126 (30 tests) or RFIT-ASY-0127 (6 tests). Also, verify if you're using the BACT/ALERT FA Plus (410851), FN Plus (410852), or PF Plus (410853) blood culture bottles.
Identify if your FilmArray Blood Culture Identification kit has catalog numbers RFIT-ASY-0126 (30 test kit) or RFIT-ASY-0127 (6 test kit).
Confirm if you're using BACT/ALERT FA Plus (410851), FN Plus (410852), or PF Plus (410853) blood culture bottles.
The kits can produce false positive results for Proteus bacteria when used with specific blood culture bottles, which could lead to incorrect diagnoses and unnecessary treatments.
BACT/ALERT FA Plus (410851), FN Plus (410852), and PF Plus (410853) blood culture bottles.
No, but you should check if your kit and bottles match the recalled items before using them. The recall does not require immediate discontinuation.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0296-2019 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-0296-2019 from BioFire Diagnostics. 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.
