Device product
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
Z-0740-2023
Product summary
- Event
- Event 91202
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12116 kits
- Official record key
device-enforcement:Z-0740-2023
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: 381177, exp 8/24/2023; 525460, exp ; 525766, exp ; 526393, exp ; 526483, exp ; 527142, exp ; 527403, exp ; 527602, exp ; 531612, exp ;
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.