BioFire Respiratory Panel 2.1 plus Kit recalled for manufacturing defect
BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 plus Kit (Lot# 1475424) due to a manufacturing error that may cause elevated control failures and false negative test results.
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 involving a diagnostic device with a risk of false negative results—a failure to detect pathogens. The source text does not report any illnesses or injuries. The hazard is a risk-of-harm scenario (missed diagnoses) where the severity is elevated due to the clinical consequence of false negatives in respiratory diagnostics, but with no reported adverse outcomes yet.
Plain-English summary
BioFire Diagnostics, LLC is recalling the BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, for use with Filmarray systems. The recall affects 30 kits that were distributed internationally to Singapore.
The recall was initiated due to a manufacturing error. This defect may result in elevated control failures and/or false negative results, meaning the diagnostic test could fail to detect respiratory pathogens when they are present.
Users of affected kits should contact BioFire Diagnostics, LLC for guidance on lot# 1475424. Healthcare facilities and laboratories using this product should review their results and consider retesting if clinically indicated.
The recalled product
- Product
- BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
- Manufacturer
- BioFire Diagnostics, LLC
- Category
- Medical Device — Diagnostic Kit
- Affected units
- 30
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)
- Lot# 1475424/ UDI: None
Distribution
Distribution scope not specified by the agency.
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