Alinity m Integrated Reaction Units — Class II medical device recall Z-0710-2022
Terminated recall by Abbott Molecular, Inc., reported 2022-03-09, distributed nationwide. There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor r
| Recall number | Z-0710-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Molecular, Inc., Des Plaines, IL, United States |
| Recall initiated | 2022-02-11 |
| Classified | 2022-03-02 |
| Reported by FDA | 2022-03-09 |
| Terminated | 2023-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 3,063 kits |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 20884999047864 |
Product
Alinity m Integrated Reaction Units (IRU)
Reason for recall
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
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-0710-2022. 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.