BioFire FilmArray BCID Panel Recalled for False Positive Proteus Results
BioFire Diagnostics is recalling the FilmArray BCID Panel due to an increased risk of false positive Proteus results when used with specific blood culture media.
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 is classified as FDA Class II, and the hazard involves a risk of improper medical treatment (improper antibiotic therapy) due to false positive results, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
BioFire Diagnostics, LLC is recalling the FilmArray BCID Panel, a qualitative multiplexed nucleic acid-based in vitro diagnostic test. The recall involves 18,501 kits distributed worldwide, including the United States and numerous international locations. The affected products are all lots of the BioFire BCID Panel used with BACT/ALERT blood culture bottles with expiration dates of September 19, 2020, and beyond.
The recall was initiated because there is an increased risk of false positive Proteus results when the test is used in conjunction with specific media types. These false positive results may lead to patients receiving improper antibiotic treatment until standard culture results are available, which typically takes 24 to 48 hours.
Healthcare providers and laboratories should stop using the affected kits and contact BioFire Diagnostics for further instructions. Consumers should not use the product and should contact their healthcare provider if they have received test results using this panel.
The recalled product
- Product
- FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT¿ FA Plus 410852/BACT/ALERT¿ FN Plus 410853/BACT/ALERT¿ PF Plus 259790/BACT/ALERT¿ SN Prod
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 18,501
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)
- 2020 and beyond.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by BioFire Diagnostics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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