Alinity i Processing Module — Class II medical device recall Z-1497-2019
Terminated recall by Abbott Gmbh & Co. KG, reported 2019-06-05, distributed nationwide. Potential loose cable connections on the reagent cooler, which could result in temperature errors and eventual
| Recall number | Z-1497-2019 |
|---|---|
| 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 | 2019-04-05 |
| Classified | 2019-05-30 |
| Reported by FDA | 2019-06-05 |
| Terminated | 2022-09-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, ES, FI, FR, GB, GR, HK, HR, ID, IL, IN, IT, JP, KR, MX, NL, NO, PH, PK, PL, PT, RO, RS, SA, SE, TH, TR, VN, ZA |
| Quantity | 373 units |
| Model numbers | 03R65, 30103732, 35006203 |
Product
Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i 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.
Reason for recall
Potential loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. Could cause burn and shock injuries to users and a delay in test results. Device design has mitigated this risk, but it is a possibility.
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-1497-2019. 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.