Device product
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Z-0739-2023
Product summary
- Event
- Event 91202
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3896 kits
- Official record key
device-enforcement:Z-0739-2023
Official wording
Reason: Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Code information: Lot Numbers: 381465, exp 8/24/2023; 524433, exp 1/5/2023; 526710, exp 1/21/2023; 527845, exp 2/8/20231499
Distribution pattern: Worldwide
Derived failure modes
-
Unknown
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.