Home › EUROIMMUN Medizinische Labordiagnostika AG › Anti-dsDNA-NcX ELISA (IgG)
Anti-dsDNA-NcX ELISA (IgG)
EUROIMMUN Medizinische Labordiagnostika AG · Model EA 1572-9601 G · UDI-DI 04049016026884
1
510(k) clearances
109
Adverse events (2 deaths)
3
Recalls
14
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-03-02 | Bio-Rad Laboratories Inc | The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits. |
| 2010-03-02 | Bio-Rad Laboratories Inc | The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits. |
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.