is a qualitative indirect enzyme immunoassay enzyme-linked… — Class III medical device recall Z-2922-2018
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-2922-2018 |
|---|---|
| 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 | 4 |
| Reason classes | labeling |
| Lot numbers | 1740 |
Product
is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
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-2922-2018. 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.