Alinity ci series System Control Module — Class II medical device recall Z-2701-2020
Terminated recall by Abbott Gmbh & Co. KG, reported 2020-08-05, distributed nationwide. Quality Control results were not properly evaluated for QC failures.
| Recall number | Z-2701-2020 |
|---|---|
| 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 | 2020-06-19 |
| Classified | 2020-07-24 |
| Reported by FDA | 2020-08-05 |
| Terminated | 2024-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, ID, IE, IL, IN, IT, JM, JO, JP, KE, KR, KW, LB, LT, LV, MA, 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 | 3,166 |
Product
Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
Reason for recall
Quality Control results were not properly evaluated for QC failures.
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-2701-2020. 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.