BioFire FilmArray BCID Panel Recalled for False Positive Proteus Results
BioFire Diagnostics is recalling FilmArray BCID Panels due to a risk of false positive Proteus results when used with specific blood culture media, which may lead to improper antibiotic treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard involves a risk of improper medical treatment (improper antibiotics) 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 5,020 kits of the FilmArray BCID Panel (RFIT-ASY-0127) used with specific BACT/ALERT blood culture bottles. The recall affects all lots of the BioFire BCID Panel used with BACT/ALERT blood culture bottles with expiration dates of September 19, 2020, and beyond. The product was distributed worldwide, including in the United States and numerous international countries.
The recall is issued because there is an increased risk of false positive Proteus results when the FilmArray BCID Panel 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 products and contact BioFire Diagnostics for further instructions. Consumers are not expected to have this product in their homes, as it is a prescription-only in vitro diagnostic test used in clinical settings.
The recalled product
- Product
- FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 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…
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 5,020
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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