BioFire Diagnostics recalls FilmArray BCID Panels that may cause false positive results for Enterobacteriaceae and E. coli when used with specific blood culture bottles. Affected units include certain model numbers and lots.
Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.
BioFire Diagnostics is recalling FilmArray BCID Panels that can produce false positive results for Enterobacteriaceae and E. coli when used with specific blood culture bottles. This could lead to incorrect diagnoses if the panels are used with the affected bottles.
The FilmArray BCID Panels can give false positive results for Enterobacteriaceae and E. coli when used with specific blood culture bottles. This means lab tests might incorrectly indicate bacterial infections, potentially leading to inappropriate treatments.
Healthcare professionals using the FilmArray BCID Panels with the listed blood culture bottles are most at risk. Patients receiving lab tests using these panels may be affected if the false positives lead to incorrect treatment.
Check if you have FilmArray BCID Panels with reference numbers RFIT-ASY-0126 or RFIT-ASY-0127. Look for blood culture bottles with part numbers 410851, 410852, or 410853 and the listed lot numbers.
Verify if your FilmArray BCID Panel has reference numbers RFIT-ASY-0126 or RFIT-ASY-0127.
Ensure your blood culture bottles are not part numbers 410851, 410852, or 410853 with the listed lot numbers.
Using the affected FilmArray BCID Panels with specific blood culture bottles can cause false positive results for Enterobacteriaceae and E. coli, which may lead to incorrect diagnoses.
Check if your FilmArray BCID Panel has reference numbers RFIT-ASY-0126 or RFIT-ASY-0127 and if your blood culture bottles have part numbers 410851, 410852, or 410853 with the listed lot numbers.
No, but you should check your panels and bottles to ensure they are not affected. If they are, you should not use them together.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1133-2019 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-1133-2019 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.
