BioFire FilmArray Blood Culture Identification Test Recall for False Positives
BioFire Diagnostics is recalling FilmArray Blood Culture Identification tests due to an increased risk of false positive results for Proteus when used with specific blood culture bottles.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a diagnostic error (false positive) rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity recall.
Plain-English summary
BioFire Diagnostics, LLC is recalling the FilmArray Blood Culture Identification (BCID) test, an in vitro diagnostic (IVD) product available by prescription only. The recall affects Panel Catalog Numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit) when used with specific BACT/ALERT blood culture bottles (FA Plus, FN Plus, or PF Plus). The recall covers 18,038 units distributed worldwide, including the United States and various international locations.
The recall was initiated because of an increased risk of false positive results for the bacterium Proteus when the product is used with the specified blood culture bottles. No specific lot numbers are excluded, as the recall applies to all lots of the affected panel catalog numbers.
Healthcare providers and laboratories should stop using the affected test kits with the specified blood culture bottles. Consumers and patients should contact their healthcare provider if they have had a recent test using this product and are concerned about the results.
The recalled product
- Product
- FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used with the following blood culture bottles: Bottle Description
- Manufacturer
- BioFire Diagnostics, LLC
- Hazard
- Affected units
- 18,038
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 lots.
Distribution
Distributed nationwide across the United States.
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