The Alinity m System is designed to automate the steps for nucleic… — Class II medical device recall Z-1665-2025
Ongoing recall by Abbott Molecular, Inc., reported 2025-04-30, distributed nationwide. The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutio
| Recall number | Z-1665-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Molecular, Inc., Des Plaines, IL, United States |
| Recall initiated | 2025-03-20 |
| Classified | 2025-04-24 |
| Reported by FDA | 2025-04-30 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00884999047389, 00884999047587, 00884999048034 |
| Serial numbers | 08N53-001 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1665-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.