BioFire Diagnostics recalls FilmArray BCID Panel (RFIT-ASY-0127) used with specific BACT/ALERT blood culture bottles due to risk of false positive Proteus results, potentially leading to improper antibiotic treatment.
There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).
BioFire Diagnostics is recalling FilmArray BCID Panel tests that could give false positive Proteus results when used with certain blood culture bottles. This might cause patients to receive incorrect antibiotics for up to 48 hours while waiting for real test results.
The test can produce false positive results for Proteus bacteria when used with certain blood culture bottles. This could lead to patients receiving the wrong antibiotics until the actual test results are available, which may take 24-48 hours.
Patients using the FilmArray BCID Panel with specific BACT/ALERT blood culture bottles may be affected. Healthcare providers who order these tests for patient blood cultures are most at risk.
Check if your FilmArray BCID Panel has the model RFIT-ASY-0127 and the unique identifier 00815381020093. It was used with BACT/ALERT blood culture bottles with expiration dates from September 19, 2020 onward.
Verify your FilmArray BCID Panel model and unique identifier to confirm if it's recalled.
The recall is due to an increased risk of false positive Proteus results when using the FilmArray BCID Panel with specific blood culture bottles, which could lead to improper antibiotic treatment.
The official recall notice does not specify a remedy or action steps for affected users.
Check if your FilmArray BCID Panel has the model RFIT-ASY-0127 and unique identifier 00815381020093, and was used with BACT/ALERT blood culture bottles with expiration dates from September 19, 2020 onward.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2296-2020 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-2296-2020 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.
