BioFire Diagnostics recalls FilmArray BCID Blood Culture Panels with specific BD BACTEC bottles, risking false Proteus results. Affected units include catalog numbers RFIT-ASY-0126 and RFIT-ASY-0127 with certain bottle lots.
There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
BioFire Diagnostics recalls FilmArray BCID Blood Culture Identification Panels that may give false positive Proteus results when used with specific BD BACTEC blood culture bottles. This could lead to incorrect infection diagnoses if the test is not properly interpreted.
The FilmArray BCID Panel can produce false positive Proteus results when paired with certain BD BACTEC blood culture bottles. This means the test might incorrectly indicate a Proteus infection when none exists, potentially leading to unnecessary treatments or missed infections.
Healthcare facilities using the FilmArray BCID Panel with the listed BD BACTEC blood culture bottles are most at risk. Patients receiving blood culture tests with these specific combinations may see inaccurate results.
Check if your FilmArray BCID Panel has catalog numbers RFIT-ASY-0126 (30 tests) or RFIT-ASY-0127 (6 tests). Also verify if you're using BD BACTEC blood culture bottles with catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, or 442191.
Identify if your FilmArray BCID Panel is catalog number RFIT-ASY-0126 (30 tests) or RFIT-ASY-0127 (6 tests).
Confirm if your BD BACTEC blood culture bottles have catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, or 442191.
The FilmArray BCID Panel may produce false positive Proteus results when used with specific BD BACTEC blood culture bottles, which could lead to incorrect infection diagnoses.
The recall does not include a remedy; you should check if your panel and bottles match the listed catalog numbers to determine if you need to switch to a different bottle type.
Yes, the BD BACTEC Blood Culture Bottles have expiration dates of 9/30/2018 and beyond.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1513-2018 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-1513-2018 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.
