Radioimmunoassay, Estriol
Clinical Chemistry · 21 CFR 862.1265
Recent MDR events
16 adverse event reports on file
- UNCONJUGATED ESTRIOLNov 12, 2024MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2024-00467
- UNCONJUGATED ESTRIOLNov 12, 2024MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2024-00468
- 1- IMMULITE 2000 UNCONJUGATED ESTRIOL (UE3)Apr 23, 2024MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2024-00293
- IMMULITE 2000 XPI UNCONJUGATED ESTRIOL (UE3)Feb 10, 2023MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2023-00051
- IMMULITE 2000 XPI UNCONJUGATED ESTRIOL (UE3)Feb 10, 2023MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2023-00052
- IMMULITE 2000 XPI UNCONJUGATED ESTRIOL (UE3)Feb 10, 2023MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2023-00053
- IMMULITE 2000 XPI UNCONJUGATED ESTRIOL (UE3)Feb 10, 2023MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2023-00054
- IMMULITE 2000 XPI UNCONJUGATED ESTRIOL (UE3)Feb 10, 2023MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2023-00055
- IMMULITE 2000 XPI UNCONJUGATED ESTRIOL (UE3)Feb 10, 2023MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2023-00057
- IMMULITE 2000 XPI UNCONJUGATED ESTRIOL (UE3)Feb 10, 2023MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2023-00056
Event type breakdown
Recalls
2 recall events for this product code
- Beckman Coulter Inc.TerminatedAug 15, 2011
Access Immunoassay Systems
The recall was initiated because Beckman Coulter has confirmed customer reports that a single lot of Access Unconjugated Estriol reagent (PIN 33570) may produce suppressed patient results and an increased incidence of IND (Indeterminate) flags. These issues have been associated with reagent lot 913348. This reagent met all testing specifications prior to release.
Z-3023-2011 · View FDA record ↗ - Beckman Coulter Inc.TerminatedUnknown
BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
Z-3006-2020 · View FDA record ↗
Registered firms
19 firms currently registered for this product code
Wallac Oy
TURKU Varsinais-Suomi, FI
Ansh Labs, Llc
Webster, TX, US
Diamond Diagnostics Inc.
Budapest, HU
American Laboratory Products Company
Salem, NH, US
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
Drg International, Inc.
Springfield, NJ, US
Getein Biotech, Inc.
Nanjing Jiangsu, CN
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Demeditec Diagnostics Gmbh
KIEL-WELLSEE Schleswig-Holstein, DE
Drg Instruments Gmbh
MARBURG Hesse, DE
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Immunocentrix Corporation
Canoga Park, CA, US
Scientific Supplies & Technology, Inc.
Doral, FL, US
Immuno-biological Laboratories, Inc.
Fridley, MN, US
Monobind, Inc.
Lake Forest, CA, US
Beckman Coulter, Inc.
CHASKA, MN, US
Diagnostics Biochem Canada, Inc.
London Ontario, CA
510(k) clearances
42 clearances for this product code
- Bayer Corp.Mar 3, 1998
K974721 · UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- Diagnostic Systems Laboratories, Inc.Aug 23, 1996
K962875 · ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
- Diagnostic Systems Laboratories, Inc.May 15, 1996
K955356 · ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
- Diagnostic Products Corp.Dec 19, 1994
K932989 · COAT-A-COUNT FREE ESTRIOL
- Wallac OYDec 9, 1994
K944490 · AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT
- Eastman Kodak CompanyMar 23, 1992
K920576 · AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
- Immunotech Corp.Aug 22, 1990
K903359 · MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT
- Sclavo, Inc.Apr 28, 1986
K860900 · IMMPULSE FREE ESTRIOL ASSAY REAGENTS