Alinity ci-series System Control Module — Class II medical device recall Z-0961-2026
Ongoing recall by Abbott Laboratories, reported 2025-12-24, distributed nationwide. Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayze
| Recall number | Z-0961-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Irving, TX, United States |
| Recall initiated | 2025-11-13 |
| Classified | 2025-12-18 |
| Reported by FDA | 2025-12-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, JP, KE, KR, KW, KY, LB, LT, LV, MA, MT, MX, MY, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VN, ZA |
| Quantity | 11,653 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00380740137410, 06952999490048 |
| Serial numbers | SCM01010, SCM01012, SCM01016, SCM01035, SCM01043, SCM01051, SCM01063, SCM01069, SCM01075, SCM01076, SCM01078, SCM01082, SCM01085, SCM01086, SCM01087, SCM01088, SCM01092, SCM01093, SCM01094, SCM01095, SCM01098, SCM01099, SCM01101, SCM01102, SCM01106 and 475 more |
| Model numbers | 03R70-01, 03R70-20 |
Product
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Reason for recall
Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.
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-0961-2026. 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.