Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay — Class II medical device recall Z-2918-2018
Terminated recall by Euro Diagnostica AB, reported 2018-08-29, distributed in MN, TX. Decreasing performance overtime.
| Recall number | Z-2918-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Euro Diagnostica AB, Malmo, Sweden |
| Recall initiated | 2016-02-14 |
| Classified | 2018-08-23 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2019-11-05 |
| Distributed | MN, TX |
| Countries outside the US | IR |
| Quantity | 25 kits |
| Lot numbers | 1737, 3092 |
Product
Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.
Reason for recall
Decreasing performance overtime.
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-2918-2018. 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.