BioFire FilmArray BCID Panel Recalled for False Positive Proteus Results
BioFire Diagnostics is recalling the FilmArray BCID Panel because it may produce false positive Proteus results when used with specific BD BACTEC blood culture bottles.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
BioFire Diagnostics, LLC is recalling the FilmArray BCID Panel (Blood Culture Identification Panel), catalog numbers RFIT-ASY-0126 and RFIT-ASY-0127, when used with specific types of BD BACTEC Blood Culture Bottles. The recall involves all lot numbers of the FilmArray BCID Panel and specific catalog numbers of the BD BACTEC bottles, including 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.
The recall is being conducted because there is an increased risk of false positive Proteus results when the product is used with the affected blood culture bottles. This issue may lead to incorrect identification of bacteria in blood cultures.
Distribution was nationwide, including military and government channels, as well as foreign distribution to numerous countries including Canada, Australia, France, Germany, Japan, and the United Kingdom. The source text does not specify the number of units recalled or report any illnesses or injuries. Users should stop using the affected products and contact BioFire Diagnostics for further instructions.
The recalled product
- Product
- FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 44226
- Manufacturer
- BioFire Diagnostics, LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot numbers are involved. UDI: 00815381020086 (RFIT-ASY-0126)
Distribution
Distributed nationwide across the United States.
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