Radioimmunoassay, Estradiol
FDA product code CHP · Class I (low risk) · 21 CFR 862.1260 · Clinical Chemistry
50510(k) clearances
0PMA approvals
30recalls
Manufacturers
- Diagnostic Products Corp. 5
- Serono-Baker Diagnostics, Inc. 4
- Diagnostic Systems Laboratories, Inc. 3
- Ciba Corning Diagnostics Corp. 2
- Biomerieux Vitek, Inc. 2
- Pantex, Div. Bio-Analysis, Inc. 2
- Boehringer Mannheim Corp. 2
- Amersham Corp. 2
- Serono Laboratories, Inc. 2
- Pharmacia, Inc. 2
- Serono Diagnostics, Inc. 1
- Ibl GmbH 1
- Baxter Healthcare Corp 1
- Terumo Medical Corp. 1
- Travenol Laboratories, S.A. 1
- Biotecx Laboratories, Inc. 1
- Sorin Biomedica, Fiat, USA, Inc. 1
- Leeco Diagnostics, Inc. 1
- Immuchem Corp. 1
- Nordiclab Intl. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041349 | Luminescent Immunoassay Kit for the Detection of Estradiol in Saliva and SerumCHP · Traditional | Ibl GmbH | 09/24/2004SE |
| K973901 | 17 B-Estradiol (Elisa)CHP · Traditional | Kmi Diagnostics, Inc. | 11/24/1997SE |
| K973743 | Access Estradiol Reagents on the Access Immunoassay AnalyzerCHP · Traditional | Beckman Instruments, Inc. | 10/31/1997SE |
| K970386 | Acs ESTADIOL-6 IICHP · Traditional | Chiron Diagnostics Corp. | 06/04/1997SE |
| K970643 | Vitros Immunodiagnostics Products Estradiol Reagent Pack(Gem. 1050)/ESTRADIOL…CHP · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 03/18/1997SE |
| K970126 | Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545)CHP · Traditional | Bio-Rad Laboratories, Inc. | 02/25/1997SE |
| K965109 | Elecsys Estradiol AssayCHP · Traditional | Boehringer Mannheim Corp. | 02/18/1997SE |
| K955647 | Vidas Estradiol II (E2II) AssayCHP · Traditional | Biomerieux Vitek, Inc. | 02/06/1996SE |
| K954697 | Ciba Corning Acs ESTRADIOL-6 AssayCHP · Traditional | Ciba Corning Diagnostics Corp. | 12/13/1995SE |
| K953605 | Ultra-Sensitive EstradiolCHP · Traditional | Diagnostic Systems Laboratories, Inc. | 10/02/1995SE |
| K951360 | Estradiol Assay for the Technicon Immuno 1 System In-Vitro Diagnostic SystemCHP · Traditional | Bayer Corp. | 05/02/1995SE |
| K946199 | Auraflex(R) EstradiolCHP · Traditional | Organon Teknika Corp. | 04/03/1995SE |
| K943193 | Coat-A-Count(R) ESTRADIOL-6CHP · Traditional | Diagnostic Products Corp. | 02/23/1995SE |
| K941168 | Clinical Assays Gammacoat [125] Estradiol Radioimmunoassay KitCHP · Traditional | Incstar Corp. | 09/07/1994SE |
| K932926 | Immulite EstradiolCHP · Traditional | Diagnostic Products Corp. | 01/10/1994SE |
| K932715 | Ciba Corning Acs Estradiol ImmunoassayCHP · Traditional | Ciba Corning Diagnostics Corp. | 12/03/1993SE |
| K932084 | Aia-Pack E2 AssayCHP · Traditional | Tosoh Medics, Inc. | 11/09/1993SE |
| K933464 | Stratus Estradiol Fluorometric Enzyme ImmunoassayCHP · Traditional | Baxter Diagnostics, Inc. | 10/22/1993SE |
| K933066 | Opus EstradiolCHP · Traditional | Pb Diagnostic Systems, Inc. | 09/08/1993SE |
| K931740 | Cotube Estradiol RadioimmunoassayCHP · Traditional | Bio-Rad | 08/16/1993SE |
| K925498 | Vidas Estradiol (E2) AssayCHP · Traditional | Biomerieux Vitek, Inc. | 02/12/1993SE |
| K920047 | Imx EstradiolCHP · Traditional | Abbott Laboratories | 02/18/1992SE |
| K913162 | Enzymun-Test EstradiolCHP · Traditional | Boehringer Mannheim Corp. | 09/27/1991SE |
| K912917 | Milenia EstradiolCHP · Traditional | Diagnostic Products Corp. | 07/30/1991SE |
| K912318 | Estradiol Serozyme Enzyme Immuno (Mag Solid-Phase)CHP · Traditional | Serono-Baker Diagnostics, Inc. | 07/25/1991SE |
| K911396 | SR1 Estradiol Enzyme ImmunoassayCHP · Traditional | Serono-Baker Diagnostics, Inc. | 05/28/1991SE |
| K910249 | Stratus Estradiol Fluoremetric EnzymeCHP · Traditional | Baxter Healthcare Corp | 02/13/1991SE |
| K902358 | Modified Delfia Estradiol KitCHP · Traditional | Pharmacia, Inc. | 06/18/1990SE |
| K896145 | Estradiol Serozyme Immunoenzymetric AssayCHP · Traditional | Serono-Baker Diagnostics, Inc. | 12/27/1989SE |
| K896270 | Amerlite ESTRADIOL-60 Assay LAN.0081/2081CHP · Traditional | Amersham Corp. | 12/12/1989SE |
| K890645 | Estradiol Maiaclone Radioimmunoassay KitCHP · Traditional | Serono-Baker Diagnostics, Inc. | 03/08/1989SE |
| K884105 | Amerlite Estradiol Assay, LAN.2080 (144 Test Kit)CHP · Traditional | Amersham Corp. | 11/16/1988SE |
| K882343 | Terumo Sensibead(Tm) Eia Estradiol KitCHP · Traditional | Terumo Medical Corp. | 07/01/1988SE |
| K882173 | Delfia Estradiol KitCHP · Traditional | Pharmacia, Inc. | 06/24/1988SE |
| K873550 | DSL Active Estradiol Ria (DSL #4300)CHP · Traditional | Diagnostic Systems Laboratories, Inc. | 02/18/1988SE |
| K870405 | DSL Estradial Radioimmunoassay (DSL-4400)CHP · Traditional | Diagnostic Systems Laboratories, Inc. | 06/08/1987SE |
| K862603 | Double Antibody Estradiol Ria KitCHP · Traditional | Diagnostic Products Corp. | 08/19/1986SE |
| K861361 | Estradiol Maia Ria Kit Magnetic Separation PhaseCHP · Traditional | Serono Diagnostics, Inc. | 06/27/1986SE |
| K853866 | Pantex Direct Estradiol Coated Tube RadioimmunoassCHP · Traditional | Pantex, Div. Bio-Analysis, Inc. | 10/15/1985SE |
| K853208 | 125I Estradiol Direct RadioimmunoassayCHP · Traditional | Travenol Laboratories, S.A. | 08/19/1985SE |
| K851540 | Estradiol Direct Ria KitCHP · Traditional | Biotecx Laboratories, Inc. | 06/06/1985SE |
| K841947 | Estradiol Direct Radioimmunoassay KitCHP · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 06/25/1984SE |
| K840051 | Coat-A-Count Estradiol KitCHP · Traditional | Diagnostic Products Corp. | 03/23/1984SE |
| K834586 | Leeco E2 Quant Diag. Test KitCHP · Traditional | Leeco Diagnostics, Inc. | 03/09/1984SE |
| K820329 | Estradiol Kit by RiaCHP · Traditional | Immuchem Corp. | 03/04/1982SE |
| K810695 | Estriol Radioimmunoassay Test KitCHP · Traditional | Serono Laboratories, Inc. | 03/31/1981SE |
| K810204 | 17B EstradiolCHP · Traditional | Pantex, Div. Bio-Analysis, Inc. | 03/27/1981SE |
| K800920 | Nordiclab Estradiol Ria TestCHP · Traditional | Nordiclab Intl. | 05/14/1980SE |
| K791652 | Estradiol Kit by RiaCHP · Traditional | Radioassay Systems Laboratories, Inc. | 09/27/1979SE |
| K790679 | Estradiol Ria KitCHP · Traditional | Serono Laboratories, Inc. | 05/23/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0867-2023 Class II | VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Biomerieux Inc | 11/09/2022Open, Classified |
| Z-1025-2022 Class II | ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the…Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient… | Siemens Healthcare Diagnostics, Inc. | 03/03/2022Open, Classified |
| Z-1024-2022 Class II | ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the…Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient… | Siemens Healthcare Diagnostics, Inc. | 03/03/2022Open, Classified |
| Z-1023-2022 Class II | ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the…Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient… | Siemens Healthcare Diagnostics, Inc. | 03/03/2022Open, Classified |
| Z-1022-2022 Class II | Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the…Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient… | Siemens Healthcare Diagnostics, Inc. | 03/03/2022Open, Classified |
| Z-1021-2022 Class II | Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative…Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient… | Siemens Healthcare Diagnostics, Inc. | 03/03/2022Open, Classified |
| Z-1020-2022 Class II | Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative…Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient… | Siemens Healthcare Diagnostics, Inc. | 03/03/2022Open, Classified |
| Z-0435-2022 Class II | VIDAS Estradiol II, REF 30431-01bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It… | bioMerieux, Inc. | 09/22/2021Open, Classified |
| Z-1514-2020 Class II | IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D)…Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely… | Siemens Healthcare Diagnostics, Inc. | 02/05/2020Terminated |
| Z-1513-2020 Class II | IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product…Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely… | Siemens Healthcare Diagnostics, Inc. | 02/05/2020Terminated |
| Z-1354-2019 Class II | Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a…Patient results may be falsely elevated. This patient impact only applies to patients currently being… | Abbott Ireland Diagnostics Division | 02/05/2019Terminated |
| Z-1353-2019 Class II | Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is…Patient results may be falsely elevated. This patient impact only applies to patients currently being… | Abbott Ireland Diagnostics Division | 02/05/2019Terminated |
| Z-0667-2019 Class II | Alinity i Estradiol Reagent Kit, List Number 07P5020Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | Abbott Ireland Diagnostics Division | 11/21/2018Terminated |
| Z-2437-2018 Class II | Dimension Vista MULTI 1 SDIL, KD693, SMN# 10469971The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective… | Siemens Healthcare Diagnostics, Inc. | 03/21/2018Terminated |
| Z-2089-2018 Class II | ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-2088-2018 Class II | ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-0515-2018 Class II | ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number…Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on… | Siemens Healthcare Diagnostics, Inc | 06/07/2017Terminated |
| Z-2608-2017 Class II | Dimension Vista Estradiol (E2) Flex reagent cartridgeThe concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and… | Siemens Healthcare Diagnostics, Inc. | 03/21/2017Terminated |
| Z-1801-2017 Class II | VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is…Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol… | BioMerieux SA | 03/17/2017Terminated |
| Z-2352-2016 Class II | VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No.…Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay.… | Ortho-Clinical Diagnostics | 07/14/2016Terminated |
| Z-0645-2017 Class II | LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay…DiaSorin is issuing an urgent medical device correction for the LIAISON Estradiol II Gen assay. Due to the… | Diasorin Inc. | 07/13/2016Terminated |
| Z-1865-2016 Class II | The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in…Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results… | Abbott Laboratories | 03/24/2016Terminated |
| Z-1277-2016 Class II | Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL…Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used… | Roche Diagnostics Operations, Inc. | 03/07/2016Terminated |
| Z-1276-2016 Class II | Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9…Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used… | Roche Diagnostics Operations, Inc. | 03/07/2016Terminated |
| Z-1243-2016 Class II | IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26…The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results. | Siemens Healthcare Diagnostics, Inc | 01/13/2016Terminated |
| Z-1242-2016 Class II | IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN:…The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results. | Siemens Healthcare Diagnostics, Inc | 01/13/2016Terminated |
| Z-1241-2016 Class II | Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product…The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results. | Siemens Healthcare Diagnostics, Inc | 01/13/2016Terminated |
| Z-1240-2016 Class II | Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889…The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results. | Siemens Healthcare Diagnostics, Inc | 01/13/2016Terminated |
| Z-0448-2011 | Access Immunoassay Systems Estradiol, Part Number: 33540 Intended use: The Access…The recall was initiated after Beckman Coulter confirmed that three lots of Access Estradiol reagent (REF… | Beckman Coulter Inc. | 03/04/2010Terminated |
| Z-0728-2007 | ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and…A small number of reagent kits were incorrectly configured. The affected kits contain either two bottles of… | Abbott Laboratories | 02/19/2007Terminated |