Alinity s System software version2 — Class II medical device recall Z-0749-2022
Ongoing recall by Abbott Laboratories, Inc, reported 2022-03-23, distributed nationwide. Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead
| Recall number | Z-0749-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Inc, Irving, TX, United States |
| Recall initiated | 2022-02-03 |
| Classified | 2022-03-11 |
| Reported by FDA | 2022-03-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BH, BR, CN, CO, CY, CZ, DE, EG, GR, HK, HR, HU, IE, IL, IR, IT, JO, KW, MX |
| Quantity | 306 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00380740138479 |
| Serial numbers | AS1001 |
| Model numbers | 06P16-01 |
Product
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.
Reason for recall
Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
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-0749-2022. 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.