BioFire BCID2 Diagnostic Panels Recalled for Temperature-Related Performance Issues
BioFire Diagnostics is recalling BioFire BCID2 diagnostic panels that experienced temperature excursions during shipment, which may reduce their performance. Affected kits were distributed in Florida and Georgia.
What this means for you
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 with no reported illnesses, injuries, or deaths. The hazard is reduced diagnostic performance from temperature exposure, which is potential rather than manifested in actual harm.
Plain-English summary
BioFire Diagnostics, LLC is recalling the BioFire BCID2 Panel, an in vitro diagnostic test kit used in clinical laboratories. The recall was initiated because products were stored outside their required temperature specifications during shipment, a result of shipping delays.
Temperature excursions can reduce the diagnostic performance of the affected test panels. This condition may affect the accuracy or reliability of test results produced by these kits.
The affected products were distributed nationwide to healthcare facilities in Florida and Georgia. No illnesses or injuries have been reported in connection with this recall.
Healthcare providers and laboratories that received affected products should discontinue use and contact BioFire Diagnostics for replacement products and additional guidance.
The recalled product
- Product
- In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
- Manufacturer
- BioFire Diagnostics, LLC
- Hazard
- temperature-excursion
- reduced-performance
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)
- Part Number: RFIT-ASY-0147 UDI: 0815381020338 Pouch Lot Number: 1766022
Distribution
Distributed nationwide across the United States.
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