Device product
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
Z-2682-2024
Product summary
- Event
- Event 94942
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 58
- Official record key
device-enforcement:Z-2682-2024
Official wording
Reason: Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
Code information: UDI-DI: 00815381020178. Lot/Expiration: 2147623/28-Aug-2024, 2147523/27-Aug-2024
Distribution pattern: Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.
Derived failure modes
-
Unknown
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.