Drug recall
DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿…
FDA recall event 79183 · Class II · Euro Diagnostica AB
Key facts
| Event ID | 79183 |
|---|---|
| Recall numbers | Z-0929-2018 |
| Recalling firm | Euro Diagnostica AB |
| Product type | Devices |
| Products | DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM… |
| Initiation date | Oct 15, 2015 |
| Report date | Mar 14, 2018 |
| Termination date | Mar 29, 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: