Z-0740-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2022
- Initiation Date
- November 22, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12116 kits
Product Description
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
Reason for Recall
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Distribution Pattern
Worldwide
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 ;