Alinity C — Class II medical device recall Z-2401-2020
Terminated recall by Abbott Gmbh & Co. KG, reported 2020-06-24, distributed in AR, CA, CO, FL, GA, KS, KY, LA…. There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amy
| Recall number | Z-2401-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Gmbh & Co. KG, Wiesbaden, Germany |
| Recall initiated | 2020-05-12 |
| Classified | 2020-06-18 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2023-01-31 |
| Distributed | AR, CA, CO, FL, GA, KS, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OK, PR, SC, SD, TN, TX, UT, VA, WI |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BM, BR, CA, CH, CL, CO, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, HK, HR, ID, IL, IN, IT, JM, JO, KE, MX, NO, OM, PH, PK, PL, PT, RO, RS, SE, SG, TH, TR, TT, UY, VN |
| Quantity | 421 serial |
Product
Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
Reason for recall
There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.
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-2401-2020. 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.