The Alinity ci-series System Control Modules which are configured… — Class II medical device recall Z-2201-2019
Terminated recall by Abbott Gmbh & Co. KG, reported 2019-08-14, distributed nationwide. All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Techno
| Recall number | Z-2201-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Gmbh & Co. KG, Wiesbaden, N/A, Germany |
| Recall initiated | 2019-05-21 |
| Classified | 2019-08-06 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2025-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CL, CN, CZ, DE, DZ, EE, ES, FI, FR, GR, HK, IE, IL, IN, JO, KE, LV, MX, NL, NO, PL, PT, SA, SE, SG, SI, TH, TR, TT, VN, ZA |
| Quantity | 943 systems |
| Reason classes | software |
Product
The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sample processing activities, and a system control module to provide a single user friendly interface. The Alinity c 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
All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Technology (ICT) assays, sodium (Na+), potassium (K+), and chloride (Cl-).
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-2201-2019. 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.