Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer… — Class II medical device recall Z-0489-2026
Ongoing recall by Abbott Laboratories, reported 2025-11-19, distributed nationwide. Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when sat
| Recall number | Z-0489-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Santa Clara, CA, United States |
| Recall initiated | 2025-09-18 |
| Classified | 2025-11-12 |
| Reported by FDA | 2025-11-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BD, BE, BG, BR, CA, CH, CL, CO, CZ, DE, DK, EG, ES, FR, GB, GR, HK, HR, HU, ID, IN, IT, JM, JO, JP, KR, KW, KY, LB, LT, MX, MY, NL, NO, OM, PA, PH, PK, PL, PT, QA, RO, RS, SA, SI, TH, TR, TT, UY, VN, ZA |
| Quantity | 833 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00380740138851 |
| Model numbers | 09P68-01 |
Product
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
Reason for recall
Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
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-0489-2026. 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.