BioFire Diagnostics recalls FilmArray BCID Panel product pouches with part numbers RFIT-ASY-0126/0127 that may cause false negative blood culture results due to manufacturing errors.
Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
BioFire Diagnostics is recalling FilmArray Blood Culture Identification Panel product pouches that may give false negative results when testing blood cultures. This could lead to incorrect diagnoses if the test fails to detect an infection.
The product pouches may have manufacturing errors that cause false negative results in blood culture tests. This means the test might incorrectly show no infection when one is present, potentially leading to missed diagnoses.
Healthcare professionals using the FilmArray BCID Panel for blood culture testing are likely affected. Those who use the product pouches with part numbers RFIT-ASY-0126 or RFIT-ASY-0127 are most at risk.
Check for product pouches labeled 'FilmArray BCID Panel' with part numbers RFIT-ASY-0126 or RFIT-ASY-0127. The pouches also have unique identifiers (UDI) 00815381020086 or 00815381020093.
Look for the product pouches with part numbers RFIT-ASY-0126 or RFIT-ASY-0127 to confirm if you have the recalled items.
BioFire Diagnostics recalls these product pouches due to complaints about false negative results in blood culture identification tests, which may be caused by a manufacturing error.
The affected part numbers are RFIT-ASY-0126 and RFIT-ASY-0127, with unique identifiers (UDI) 00815381020086 or 00815381020093.
The recall does not require stopping use immediately; however, you should check if you have the affected pouches and consider using a different product if you have false negatives.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2245-2021 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-2245-2021 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.
