FDA Device recall Z-0884-2022
Alinity m HBV AMP Kit (US and CE)
- FDA Device
- Class II
- ongoing
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Alinity m HBV AMP Kit (US and CE) by Abbott Molecular, citing there is a potential for misquantitation high results for negative samples.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0884-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-04 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Molecular |
| Distribution | AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, VA |
Product
Alinity m HBV AMP Kit (US and CE)
Reason
There is a potential for misquantitation high results for negative samples.
Identifiers
| code_info | List Numbers: 1) 08N47-095 (US); Lots: 519756, 523799, and 524361, Updated to add: 381583, 529391, 529687, 530273, 53…List Numbers: 1) 08N47-095 (US); Lots: 519756, 523799, and 524361, Updated to add: 381583, 529391, 529687, 530273, 531598; 2) 08N47-090 (CE); Lots: 519755, 520957, 522137, 523798, and 524059, Updated to add: 380963, 380979, 381021, 529378, 529686, 530272, 531189, 531596 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0884-2022%22
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