FDA Device recall Z-1665-2025
The Alinity m System is designed to automate the steps for nucleic acid testing
- FDA Device
- Class II
- ongoing
- Published 2025-04-30
On 2025-04-30 the FDA classified a Class II recall of The Alinity m System is designed to automate the steps for nucleic acid testing by Abbott Molecular, citing the design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the foo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1665-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-20 |
| Published | 2025-04-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Molecular |
| Distribution | US |
Product
The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).
Reason
The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.
Identifiers
| code_info | All Serial Numbers. 08N53-001, UDI-DI: 00884999047389; 08N53-002, UDI-DI: 00884999048034; 08N53-032, UDI-DI: 00884999047587 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1665-2025%22
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