Alinity c Cuvette Segments — Class II medical device recall Z-1709-2019
Terminated recall by Abbott Gmbh & Co. KG, reported 2019-06-12, distributed nationwide. Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height. Thi
| Recall number | Z-1709-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Gmbh & Co. KG, Wiesbaden, Germany |
| Recall initiated | 2019-04-15 |
| Classified | 2019-06-02 |
| Reported by FDA | 2019-06-12 |
| Terminated | 2020-10-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BR, CA, CL, CZ, DE, EE, ES, FI, FR, GB, GR, HK, HR, ID, IE, IL, IN, IT, JO, KE, KW, LB, LT, LV, MX, MY, NL, NO, PH, PK, PL, PT, RO, RS, SA, SE, SG, SI, TH, TR, TT, VN, ZA |
| Quantity | 19,184 |
Product
Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology.
Reason for recall
Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height. This may result in inadequate dispense into specific cuvettes due to the sample probe being unable to make efficient contact with the cuvette bottom.
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-1709-2019. 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.