Blood Culture Identification Panel Recalled Due to Manufacturing Defect
BioFire BCID2 panels for FilmArray Systems are recalled due to manufacturing defects causing elevated rates of false negative results. Affected diagnostic kits may fail to detect infections in blood culture samples.
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: This is an FDA Class II recall of a diagnostic device where manufacturing defects may cause false negative results. While the device poses a risk of harm through potentially undetected infections, no illnesses, injuries, or hospitalizations are reported in the source text.
Plain-English summary
BioFire Diagnostics, LLC is recalling the BioFire BCID2 Panel (Reference RFIT-ASY-0147), a blood culture identification test for use with FilmArray Systems. The recall affects approximately 870 kits distributed nationwide. The issue stems from a manufacturing process error where some pouches contained the wrong component—specifically, the optical packaging material (OPP) from the older FilmArray BCID panel instead of the BCID2 panel. This manufacturing defect can result in elevated rates of false negative results when performing blood culture identification testing.
False negative results in blood culture identification mean that infections present in a patient's blood sample may not be detected by the test. This poses a significant risk in clinical settings where accurate and timely identification of bloodstream infections is critical for proper patient treatment.
Healthcare providers currently using affected kits (Pouch Lot# 11YA20 / Kit Lot# 2039020) should stop using them immediately and verify their lot numbers against the recall information. BioFire Diagnostics should be contacted regarding replacement or proper handling of affected inventory. Any instances of suspected false negative results in patients tested with affected kits should be reported to BioFire Diagnostics and the FDA.
The recalled product
- Product
- BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
- Manufacturer
- BioFire Diagnostics, LLC
- Hazard
- Affected units
- 870
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)
- Pouch Lot# 11YA20/ Kit Lot# 2039020. UDI: (01)00815381020338
Distribution
Distributed nationwide across the United States.
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