is a quantitative/qualitative enzyme-linked immunosorbent assay — Class III medical device recall Z-2921-2018
Terminated recall by Euro Diagnostica AB, reported 2018-08-29, distributed in MN. Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
| Recall number | Z-2921-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Euro Diagnostica AB, Malmo, Sweden |
| Recall initiated | 2016-10-21 |
| Classified | 2018-08-23 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2019-11-05 |
| Distributed | MN |
| Quantity | 6 |
| Reason classes | labeling |
| Lot numbers | 2819 |
Product
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders.
Reason for recall
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
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-2921-2018. 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.