FDA Device recall Z-1518-2022
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
- FDA Device
- Class II
- completed
- Published 2022-08-24
On 2022-08-24 the FDA classified a Class II recall of The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use by Abbott Molecular, citing incorrect optical calibration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1518-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-07-19 |
| Published | 2022-08-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Molecular |
| Distribution | n/a |
Product
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Reason
Incorrect optical calibration
Identifiers
| code_info | Serial Number 00654 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1518-2022%22
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