Abbott Alinity ci-series System Control Module software version 2 — Class II medical device recall Z-1316-2019
Terminated recall by Abbott Gmbh & Co. KG, reported 2019-05-22, distributed in AR, AZ, CA, FL, GA, IL, MA, ME…. Potential performance issues in the Alinity-ci software version 2.5.1
| Recall number | Z-1316-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Gmbh & Co. KG, Wiesbaden, Germany |
| Recall initiated | 2019-03-07 |
| Classified | 2019-05-13 |
| Reported by FDA | 2019-05-22 |
| Terminated | 2025-02-19 |
| Distributed | AR, AZ, CA, FL, GA, IL, MA, ME, MN, MO, NY, OK, PR, SC, TN, TX, UT, VA, WI |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EE, ES, FI, FR, GB, GR, GT, HK, HR, ID, IL, IT, JO, JP, KE, KR, KW, LB, LV, MX, MY, NL, NO, NZ, PH, PK, PL, PT, RO, RS, SA, SE, SG, SK, TH, TR, TT, TW, VN, ZA |
| Quantity | 1,557 |
| Reason classes | software |
Product
Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN 03R65 01) processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples. The Alinity c (LN 03R67 01) processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c processing module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).
Reason for recall
Potential performance issues in the Alinity-ci software version 2.5.1
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-1316-2019. 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.