Agglutination Method, Human Chorionic Gonadotropin
Clinical Chemistry · 21 CFR 862.1155
Recent MDR events
171 adverse event reports on file
- ICON 20 HCG PREGNANCY TESTFeb 1, 2023MalfunctionBeckman Coulter, Inc.MW5114626
- ICON 20 HCG PREGNANCY TESTFeb 1, 2023MalfunctionBeckman Coulter, Inc.MW5114628
- ICON 20 HCG PREGNANCY TESTFeb 1, 2023MalfunctionBeckman Coulter, Inc.MW5114629
- ICON 20 HCG PREGNANCY TESTFeb 1, 2023MalfunctionBeckman Coulter, Inc.MW5114630
- CLINITEK STATUSApr 2, 2018MalfunctionSiemens Healthcare Diagnostics, Inc.7388068
- TARGET HCG URINE CONTROL SETAug 6, 2014MalfunctionMyers-stevens GroupMW5037694
- CLINITEK STATUS ANALYZERJan 6, 2012MalfunctionSiemens Healthcare Diagnostics, Mfg., Ltd.1217157-2011-00054
- CLINITEK STATUS+ ANALYZERDec 14, 2011OtherSiemens Healthcare Diagnostics, Manufacturing Ltd.1217157-2011-00050
- CLINITEK STATUS ANALYZERDec 13, 2011MalfunctionSiemens Healthcare Diagnostics, Manufacturing Ltd.1217157-2011-00047
- CLINITEK STATUS ANALYZERDec 12, 2011MalfunctionSiemens Healthcare Diagnostics, Manufacturing Ltd.1217157-2011-00049
Event type breakdown
Recalls
3 recall events for this product code
- PerkinElmer Life and Analytical Sciences, Wallac, OYOpen, ClassifiedUnknown
DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Z-1237-2019 · View FDA record ↗ - PerkinElmer Life and Analytical Sciences, Wallac, OYOpen, ClassifiedUnknown
AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Z-1238-2019 · View FDA record ↗ - PerkinElmer Life and Analytical Sciences, Wallac, OYOpen, ClassifiedUnknown
AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Z-1239-2019 · View FDA record ↗
Registered firms
2 firms currently registered for this product code
510(k) clearances
96 clearances for this product code
- Immunostics Inc.,Aug 29, 1997
K972606 · PREGNACOL PREGNANCY TEST
- Tech-Co, Inc.Jun 28, 1996
K921968 · IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST
- Sa Scientific, Inc.Feb 24, 1994
K935863 · SAS(TM) DIRECT MONOCLONAL HCG
- J.S. Medical Assoc.Jul 28, 1993
K926112 · ACCUTEX BETA-HCG TEST
- Sa Scientific, Inc.Mar 29, 1993
K930609 · SAS(TM) MONOCLONAL HCG-SLIDE
- Tech-Co, Inc.Mar 24, 1992
K920716 · DIRECT PREGNANCY TEST
- Unipath , Ltd.Apr 1, 1991
K910946 · CLEARVIEW HCG
- Organon Teknika Corp.May 27, 1988
K881435 · PREGNOSPIA II