Device product
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Z-1448-2020
Product summary
- Firm
- Biofire Defense
- Event
- Event 84887
- Status
- Terminated
- Classification
- Class III
- Quantity
- 92 kits
- Official record key
device-enforcement:Z-1448-2020
Official wording
Reason: The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.
Code information: Lot No./Expiration Date 457117D/2018-10-17 416118D/2019-03-15 439218D/2019-06-12 439318D/2019-07-18 454218D/2019-08-21 454318D/2019-08-22 455518D/2019-08-23 458118D/2019-09-18 458218D/2019-09-19 458018D/2019-09-20 464018D/2019-10-02 425719D/2020-05-30 462819D/2020-06-10
Distribution pattern: US: UT, MD, GA, CO, OH, TX, OUS: None
Derived failure modes
-
Unknown
The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.