BioFire FilmArray Blood Culture Identification Panel Recalled for False Positives
BioFire is recalling the FilmArray Blood Culture Identification Panel due to an increased risk of false positive results when used with specific blood culture bottles.
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: The recall is classified as FDA Class II. The hazard involves false positive diagnostic results, which is a moderate risk of misdiagnosis or unnecessary treatment, but the source does not report any hospitalizations, serious injuries, or deaths.
Plain-English summary
BioFire Diagnostics, Inc. is recalling the FilmArray Blood Culture Identification (BCID) Panel, Model 2.0. This in vitro diagnostic test is designed to identify organisms in positive blood cultures. The recall involves 1,084 units distributed worldwide, including the United States, the European Union, Hong Kong, and Vietnam.
The recall was initiated because BioFire identified an increased risk of false positive results when the FilmArray BCID Panel is used with bioMérieux BacT/ALERT Standard Anaerobic (SN) blood culture bottles. Specifically, false positive results have been observed for Pseudomonas aeruginosa and Enterococcus.
Healthcare facilities and laboratories that have purchased this product should stop using the FilmArray BCID Panel with bioMérieux BacT/ALERT Standard Anaerobic (SN) blood culture bottles. Users should contact BioFire Diagnostics for instructions on how to return the affected units.
The recalled product
- Product
- FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designed to test positive blood cultures to quickly identify the organism that is…
- Manufacturer
- BioFire Diagnostics, Inc.
- Hazard
- Affected units
- 1,084
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 (20)
- 426614
- 424514
- 424014
- 421114
- 419114
- 419214
- 417814
- 416214
- 416114
- 411214
- 411314
- 411014
- 410414
- 410014
- 408414
- 406314
- 404314
- 402314
- 403613
- 700113
Distribution
Distributed nationwide across the United States.
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