Blood Culture Identification Panel Quality Control Test Reporting Issue
BioFire Diagnostics is recalling BIOFIRE Blood Culture Identification 2 (BCID2) Panels due to instrument characteristic changes that cause Candida tropicalis to be detected but reported as 'Not Detected' in quality control testing.
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 2/5 (Moderate).
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: This is an FDA Class II recall involving a false negative reporting issue in quality control testing. No illnesses, injuries, or deaths have been reported. The hazard is a test accuracy issue requiring procedural amendment.
Plain-English summary
BioFire Diagnostics, LLC is recalling the BIOFIRE Blood Culture Identification 2 (BCID2) Panel (REF: RFIT-ASY-0147) and Maine Molecular Quality Controls, Inc. (MMQCI) FilmArray BCID2 Control Panel M416 used with it. Approximately 32,910 units have been distributed worldwide to clinical laboratories and diagnostic facilities.
Routine quality control testing with affected panels may yield inaccurate results due to control panel and instrument characteristic changes. Specifically, Candida tropicalis is amplified by the assay during some test runs but is reported as 'Not Detected' because the assay amplicon melting temperature (Tm) falls outside the acceptable limit assigned for calling positive results.
The affected products are used in clinical laboratory and diagnostic settings worldwide, including in all 50 U.S. states and numerous countries internationally.
The recalled product
- Product
- BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels…
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 32,910
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)
- REF/UDI-DI: RFIT-ASY-0147/00815381020338. FLM1-PRT-0251-16 and prior.
Distribution
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