Radioimmunoassay, Androstenedione
Clinical Chemistry · 21 CFR 862.1075
Recent MDR events
125 adverse event reports on file
- IMMULITE 2000 ANDROSTENEDIONEFeb 20, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00044
- IMMULITE 2000 ANDROSTENEDIONEFeb 20, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00045
- IMMULITE 2000 ANDROSTENEDIONEFeb 19, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00043
- IMMULITE 2000 ANDROSTENEDIONEFeb 17, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00039
- IMMULITE 2000 ANDROSTENEDIONEFeb 17, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00040
- IMMULITE 2000 ANDROSTENEDIONEFeb 17, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00041
- IMMULITE 2000 ANDROSTENEDIONEMar 2, 2017MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2017-00158
- IMMULITE 2000 ANDROSTENEDIONEDec 20, 2016MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2016-00778
- IMMULITE 2000 ANDROSTENEDIONEDec 8, 2014MalfunctionSiemens Healthcare Diagnostics Products Limited2432235-2014-00692
- IMMULITE 2000 ANDROSTENEDIONEDec 8, 2014MalfunctionSiemens Healthcare Diagnostics Products Limited2432235-2014-00691
Event type breakdown
Recalls
5 recall events for this product code
- Siemens Healthcare Diagnostics Inc.TerminatedJul 15, 2014
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
Z-2058-2014 · View FDA record ↗ - Siemens Healthcare DiagnosticsTerminatedApr 30, 2014
IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siemens Healthcare Diagnostics Products Ltd
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 Androstenedione assays (LKAO1, L2KAO2). Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL, instead of 10 ng/mL as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 and 10 ng/mL will detect this issue.
Z-1531-2014 · View FDA record ↗ - Siemens Healthcare DiagnosticsTerminatedApr 30, 2014
IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188, IVD, 200 test kit size --- Siemens Healthcare Diagnostics Products Lt
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 Androstenedione assays (LKAO1, L2KAO2). Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL, instead of 10 ng/mL as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 and 10 ng/mL will detect this issue.
Z-1532-2014 · View FDA record ↗ - Diasorin Inc.TerminatedApr 13, 2005
DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum. Catalog No. CA-1725. Lot # 04164.
Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution. The assay validation criteria failed when the gelatinous standards were used.
Z-0704-05 · View FDA record ↗ - Diasorin Inc.TerminatedMar 18, 2005
DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725, DiaSorin Stillwater, Minnesota 55082-0285, U.S.A. Lot # 05144. for the quantitative d
Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.
Z-0634-05 · View FDA record ↗
Registered firms
19 firms currently registered for this product code
American Laboratory Products Company
Salem, NH, US
Monobind, Inc.
Lake Forest, CA, US
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Diagnostics Biochem Canada, Inc.
London Ontario, CA
Siemens Healthcare Diagnostics Inc.
E Walpole, MA, US
Immuno-biological Laboratories, Inc.
Fridley, MN, US
Drg Instruments Gmbh
MARBURG Hesse, DE
Immunodiagnostic Systems Ltd.
Boldon Colliery Durham, GB
Mp Biomedicals Diagnostics Division
Solon, OH, US
Immunocentrix Corporation
Canoga Park, CA, US
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Diasource Immunoassays, Sa
Louvain-La-Neuve Brabant Wallon, BE
Diasorin Inc.
Stillwater, MN, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Drg International, Inc.
Springfield, NJ, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Demeditec Diagnostics Gmbh
KIEL-WELLSEE Schleswig-Holstein, DE
510(k) clearances
10 clearances for this product code
- Diagnostic Systems Laboratories, Inc.Aug 16, 1996
K963002 · ACTIVE ANDROSTENEDIONE EIA
- Diagnostic Products Corp.Nov 29, 1995
K954755 · COAT-A-COUNT DIRECT ANDROSTENEDIONE
- Diagnostic Systems Laboratories, Inc.Jan 10, 1994
K934751 · ACTIVE ANDROSTANEDIOL GLUCURONIDE
- Immuchem Corp.Mar 14, 1986
K860559 · ANDROSTENEDIONE 125I KIT BY RIA
- Diagnostic Systems Laboratories, Inc.Jan 22, 1986
K854673 · DSL ANDROSTENEDIONE RIA (DSL # 4200)
- Diagnostic Systems Laboratories, Inc.Dec 13, 1985
K854650 · DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)
- Diagnostic Products Corp.Dec 10, 1984
K844398 · COAT-A-COUNT ANDROSTENEDIONE RIA KIT
- Radioassay Systems Laboratories, Inc.Sep 27, 1984
K842960 · ANDROSTENEDIONE BY RIA