Abbott Alinity i Processing Module LN 03R65-01 — Class II medical device recall Z-1196-2019
Terminated recall by Abbott Gmbh & Co. KG, reported 2019-04-24, distributed nationwide. The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy
| Recall number | Z-1196-2019 |
|---|---|
| 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 | 2019-02-26 |
| Classified | 2019-04-18 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2022-09-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EE, ES, FI, FR, GB, GR, GT, HK, HR, ID, IE, IL, IN, IT, JO, JP, KE, KR, LB, LV, MX, MY, NL, NO, NZ, PH, PK, PL, PT, RO, RS, SA, SE, SG, SI, TH, TR, TT, TW, VN, ZA |
| Quantity | 1,097 |
Product
Abbott Alinity i Processing Module LN 03R65-01 - 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
The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity s System.
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-1196-2019. 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.