Device product
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Z-2440-2023
Product summary
- Event
- Event 92397
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24 Kits (30 pouches/kit)
- Official record key
device-enforcement:Z-2440-2023
Official wording
Reason: Due to manufacturing issue, panels may result in false negative results.
Code information: Pouch Lot # 2NBT22 /Kit # 2187822 ;UDI-DI: UDI: 00815381020482
Distribution pattern: US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia
Derived failure modes
-
Unknown
Due to manufacturing issue, panels may result in false negative results.