Alinity Reaction Vessels — Class III medical device recall Z-0958-2023
Ongoing recall by Abbott Laboratories, reported 2023-01-25, distributed in IL, MN, MO, NC, ND, NJ, NY, OK…. Reaction vessels may contain a potential contaminant that could affect their optical performance.
| Recall number | Z-0958-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Irving, TX, United States |
| Recall initiated | 2022-11-24 |
| Classified | 2023-01-17 |
| Reported by FDA | 2023-01-25 |
| Distributed | IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV |
| Quantity | 70 cases |
| UPC / GTIN / UDI-DI | 00380740129026 |
| Lot numbers | 000586879, 00380740129026/000586790 |
| Model numbers | 06P1401 |
Product
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Reason for recall
Reaction vessels may contain a potential contaminant that could affect their optical performance.
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-0958-2023. 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.