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IDS Androstenedione

IMMUNODIAGNOSTIC SYSTEMS LIMITED · Model IS-5400 · UDI-DI 05060169691261

CIZ Prescription

510(k) clearances

125

Adverse events

Recalls

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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Data 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.