Drug recall
is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in…
FDA recall event 80684 · Class III · Euro Diagnostica AB
Key facts
| Event ID | 80684 |
|---|---|
| Recall numbers | Z-2919-2018, Z-2920-2018, Z-2921-2018, Z-2922-2018 |
| Recalling firm | Euro Diagnostica AB |
| Product type | Devices |
| Products | 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…, is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin…, 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…, 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. |
| Initiation date | Oct 21, 2016 |
| Report date | Aug 29, 2018 |
| Termination date | Nov 5, 2019 |
| City | Malmo |
| Country | Sweden |
| FEI number | 3007610287 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: