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ANST AccuBind ELISA Test System - 192 Wells
MONOBIND, INC. · Model 12425-300 · UDI-DI 00816870024707
CIZ
Prescription
10
510(k) clearances
125
Adverse events
5
Recalls
20
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-06-09 | Siemens Healthcare Diagnostics Inc. | The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms. |
| 2013-12-20 | Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi And |
| 2013-12-20 | Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi And |
| 2004-07-15 | Diasorin Inc. | Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution. |
| 2004-05-25 | Diasorin Inc. | Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution. The assay validation criteria failed when the gel |
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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.