Device product
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Z-1877-2025
Product summary
- Event
- Event 96835
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30 kits
- Official record key
device-enforcement:Z-1877-2025
Official wording
Reason: Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Code information: Lot# 1475424/ UDI: None
Distribution pattern: International distribution in the country of Singapore.
Derived failure modes
-
Manufacturing or process control
manufacturing error