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Diamedix
DIAMEDIX CORPORATION · Model 720-700 · UDI-DI 00817273020372
1
510(k) clearances
109
Adverse events (2 deaths)
3
Recalls
14
Facilities
Description
"720-700 anti-dsDNA Test Kit"
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, |
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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.