LN 3R70-01 — Class II medical device recall Z-1580-2020
Terminated recall by Abbott Gmbh & Co. KG, reported 2020-04-01, distributed nationwide. Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earli
| Recall number | Z-1580-2020 |
|---|---|
| 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 | 2020-01-24 |
| Classified | 2020-03-26 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2023-08-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BH, BM, BR, CA, CH, CL, CN, CR, CZ, DE, DK, EE, ES, FI, FR, GB, GR, GT, HK, HR, ID, IE, IL, IN, IT, JM, JO, JP, KE, KR, KW, LB, LT, LV, MX, MY, NL, NO, NZ, OM, PE, PH, PK, PL, PT, RO, RS, RU, SA, SE, SG, SI, SK, TH, TR, TT, TW, UA, UY, VN, ZA |
| Quantity | 2,676 units |
| Reason classes | software |
Product
LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.
Reason for recall
Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.
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-1580-2020. 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.