FDA Device recall Z-0461-2022
Alinity m System, Part No. 08N53-002
- FDA Device
- Class II
- ongoing
- Published 2022-01-12
On 2022-01-12 the FDA classified a Class II recall of Alinity m System, Part No. 08N53-002 by Abbott Molecular, citing there is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0461-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-12-06 |
| Published | 2022-01-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Molecular |
| Distribution | US |
Product
Alinity m System, Part No. 08N53-002
Reason
There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
Identifiers
| code_info | Alinity m System, Model 08N53-002, all serial numbers |
|---|
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-0461-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.