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Human Complement C1q BINDARID™ Radial Immunodiffusion Kit
THE BINDING SITE GROUP LIMITED · Model RN020.3 · UDI-DI 05051700010511
DAK
Prescription
1
510(k) clearances
0
Adverse events
3
Recalls
9
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-04-04 | Diagnostic Hybrids, Inc. | There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay. |
| 2015-11-03 | Diagnostic Hybrids, Inc. | A component of the kit was found to contain bacterial contamination. |
| 2009-10-28 | Inova Diagnostics Incorporated | The recall was initiated after the binding site notified Inova Diagnostics, inc. that the affected Bindazyme Human C1q binding Circulating Immune Complex EIA Kits may contain an EL |
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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.