Device product
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Z-1518-2025
Product summary
- Event
- Event 96346
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 29 kits
- Official record key
device-enforcement:Z-1518-2025
Official wording
Reason: Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Code information: UDI: 00815381020314/Lot# 0979424
Distribution pattern: OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
Derived failure modes
-
Unknown
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.