Radioimmunoassay, Thyroid-Stimulating Hormone
FDA product code JLW · Class II (moderate risk) · 21 CFR 862.1690 · Clinical Chemistry
242510(k) clearances
0PMA approvals
45recalls
Manufacturers
- Siemens Healthcare Diagnostics, Inc. 10
- Abbott Laboratories 10
- Bd Becton Dickinson Vacutainer Systems Preanalytic 9
- Bio-Rad 9
- Micromedic Systems 8
- Diagnostic Products Corp. 8
- Corning Medical & Scientific 7
- Amersham Corp. 5
- Hybritech, Inc. 4
- Ciba Corning Diagnostics Corp. 4
- Beckman Coulter Inc. 4
- Ventrex Laboratories, Inc. 4
- Immunotech Corp. 3
- Monobind 3
- Pacific Biotech, Inc. 3
- Nichols Institute Diagnostics 3
- Boehringer Mannheim Corp. 3
- Pcl-Ria, Inc. 3
- Medix Biotech, Inc. 3
- Nuclear Medical Laboratories, Inc. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII)JLW · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/06/2026SE |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI…JLW · Traditional | Siemens Healthcare Diagnostics | 04/25/2025SE |
| K234091 | Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0JLW · Traditional | Genalyte, Inc. | 07/22/2024SE |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII)JLW · Traditional | Siemens Healthcare Diagnostics, Inc. | 04/04/2024SE |
| K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL)…JLW · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2023SE |
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerJLW · Traditional | Beckman Coulter, Inc. | 11/10/2022SE |
| K190773 | Elecsys TSHJLW · Traditional | Roche Diagnostics | 04/16/2019SE |
| K170232 | AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerJLW · Traditional | Boditech Med, Inc. | 10/13/2017SE |
| K171103 | Lumipulse G TSH-III Immunoreaction CartridgesJLW · Traditional | Fujirebio Diagnostics,Inc. | 07/28/2017SE |
| K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerJLW · Traditional | Shenzhen New Industries Biomedical Engineering… | 07/14/2017SE |
| K162606 | Elecsys TSH assay, cobas e 801 Immunoassay analyzerJLW · Traditional | Roche Diagnostics | 01/23/2017SE |
| K160541 | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator…JLW · Traditional | Sysmex America, Inc. | 10/21/2016SE |
| K153651 | Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay…JLW · Traditional | Beckman Coulter, Inc. | 08/18/2016SE |
| K160647 | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4JLW · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/31/2016SE |
| K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators…JLW · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/20/2015SE |
| K150403 | ADVIA Centaur TSH3-UltraJLW · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/01/2015SE |
| K141999 | Advia Centaur TSHJLW · Special | Siemens Healthcare Diagnostics, Inc. | 04/22/2015SE |
| K131928 | Frend TSH (Reagent Cartridge)JLW · Traditional | Nanoentek USA, Inc. | 03/14/2014SE |
| K130469 | Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control…JLW · Traditional | DiaSorin, Inc. | 04/05/2013SE |
| K110761 | Mict TSHJLW · Traditional | Magnabiosciences, LLC | 03/09/2012SE |
| K101390 | Fastpack TSH ImmunoassayJLW · Special | Qualigen, Inc. | 08/13/2010SE |
| K090846 | GSP Instrument and GSP Neonatal HTSH KitJLW · Traditional | Perkinelmer, Inc. | 09/03/2009SE |
| K083844 | Advia Centaur TSH3-ULTRA MethodJLW · Traditional | Siemens Healthcare Diagnostics | 05/08/2009SE |
| K083173 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600…JLW · Special | Ortho-Clinical Diagnostics | 12/22/2008SE |
| K081543 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600…JLW · Special | Ortho-Clinical Diagnostics, Inc. | 10/23/2008SE |
| K081074 | Dimension TSHL Flex Reagent Cartridge and TSH Sample Diluent with Models RF 612 and KD691JLW · Special | Siemens Healthcare Diagnostics, Inc. | 05/23/2008SE |
| K072458 | Gbi TSH Neonatal Screening KitJLW · Traditional | Golden Bridge International, Inc. | 04/10/2008SE |
| K063437 | Accubind Neo-Tsh Microwell Elisa, Model 3425-300JLW · Traditional | Monobind, Inc. | 04/04/2008SE |
| K062581 | Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay SystemJLW · Traditional | Olympus America, Inc. | 11/29/2006SE |
| K060090 | Dimension Vista Thyroid Stimulating Hormone Flex Reagent CartridgeJLW · Traditional | Dade Behring, Inc. | 02/27/2006SE |
| K052301 | Fastpack TSH ImmunoassayJLW · Traditional | Qualigen, Inc. | 01/04/2006SE |
| K042281 | Modification to Access Hypersensitive HTSH AssayJLW · Special | Beckman Coulter, Inc. | 09/16/2004SE |
| K041014 | TSH-CTK-3 IrmaJLW · Traditional | DiaSorin, Inc. | 07/14/2004SE |
| K030912 | Thyro TestJLW · Traditional | Thryotec | 07/25/2003SE |
| K023093 | Access Hypersensitive HTSH AssayJLW · Traditional | Beckman Coulter, Inc. | 11/25/2002SE |
| K013420 | Chemwell, Also Known AS Project 2900JLW · Abbreviated | Awareness Technology, Inc. | 07/19/2002SE |
| K011527 | Praxsys Relia TSH TestJLW · Traditional | Praxsys Biosystems, Inc. | 08/07/2001SE |
| K011525 | Safe at Home TSH (Thyroid Stimulating Hormone Blood Collection and Transport System)JLW · Traditional | Biosafe Laboratories, Inc. | 07/16/2001SE |
| K003752 | Biosafe Capillary Blood Transport System for Testing Thyroid Stimulating Hormone (TSH)JLW · Traditional | Biosafe Laboratories, Inc. | 03/23/2001SE |
| K001455 | Accuwell TSH, Model KAW-TSH-960JLW · Traditional | Neometrics, Inc. | 11/02/2000SE |
| K001606 | Reprobead TSH Enzyme Immunoassay Reagent Kit (Catalog# 107)JLW · Traditional | Repromedix Corp. | 10/05/2000SE |
| K991146 | TSH Enzyme Immunoassay Test Kit, Model #BC-1001JLW · Traditional | Biocheck, Inc. | 06/22/1999SE |
| K990993 | Biocheck Sensitive TSH (S-Tsh) Enzyme Immunoassay Test Kit; Catalog Number: BC-1003JLW · Traditional | Biocheck, Inc. | 06/22/1999SE |
| K990658 | Thyrochek One-Step Whole Blood Rapid TSH AssayJLW · Traditional | Little Nell Labs, Inc. | 06/02/1999SE |
| K983442 | Abbott Architect TSHJLW · Traditional | Abbott Laboratories | 11/20/1998SE |
| K981312 | 3RD Generation TSH Assay for the Bayer Immuno 1 SystemJLW · Traditional | Bayer Corp. | 06/05/1998SE |
| K981060 | Abbott Axsym 3RD Generation TSH AssayJLW · Traditional | Abbott Laboratories | 04/29/1998SE |
| K980574 | Auraflex TSH-3 200 Test Pack Model Number 80600, Auraflex TSH-3 Calibrator Pack Model…JLW · Traditional | Alfa Biotech (Uk) , Ltd. | 03/24/1998SE |
| K973276 | Autodelfia Neonatal HTSH L Kit (B077-112)JLW · Traditional | Eg &G Wallac | 11/20/1997SE |
| K972586 | Aia-Pack TSH 3RD-GEN AssayJLW · Traditional | Tosoh Medics, Inc. | 08/29/1997SE |
| K971780 | Thyrotropin(Tsh) ElisaJLW · Traditional | Monobind | 06/24/1997SE |
| K970393 | Thyroid Stimulating Hormone MethodJLW · Traditional | Dade Chemistry Systems, Inc. | 03/03/1997SE |
| K964558 | Vitros Immunodiagnostics Products/Tsh Reagent Pack (Gem. 1001)/TSH CALIBRATORS(GEM.C001)JLW · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 12/16/1996SE |
| K961566 | Biocircuits Ios TSH Test Cartridges/Thyroid ControlsJLW · Traditional | Biocircuits Corp. | 11/18/1996SE |
| K962464 | Scantibodies Laboratory TSH Immunoradiometric Assay (Irma)(Coated Tube Technology)JLW · Traditional | Scantibodies Laboratory, Inc. | 10/08/1996SE |
| K962216 | TSH (Microwell) ElisaJLW · Traditional | Biomerica, Inc. | 09/19/1996SE |
| K961629 | Thyroid Stiumlating Hormone (Tsh-Beads Assay) TestJLW · Traditional | Teco Diagnostics | 09/11/1996SE |
| K961491 | Elecsys TSH AssayJLW · Traditional | Boehringer Mannheim Corp. | 07/22/1996SE |
| K961650 | Nichols Advantage Chemiluminescence Thyroid Stimulating Hormone Third Generation KitJLW · Traditional | Nichols Institute Diagnostics | 07/16/1996SE |
| K960195 | Thyrochek One-Step Rapid TSH AssayJLW · Traditional | Franklin Diagnostics, Inc. | 04/15/1996SE |
| K954825 | Access Hypersensitive TSH Reagents on the Access Immunoassay AnalyzerJLW · Traditional | Bio-Rad Laboratories, Inc. | 11/21/1995SE |
| K952211 | Amerlite TSH-30 Ultrasensitive Assay (LAN.0010Q/2010Q)JLW · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 07/14/1995SE |
| K952148 | Axsym Ultrasensitive HTSH IIJLW · Traditional | Abbott Laboratories | 06/29/1995SE |
| K951796 | Ciba Corning Acs Thyroid Stimulating Hormone (TSH-3) ImmunoassayJLW · Traditional | Ciba Corning Diagnostics Corp. | 06/13/1995SE |
| K950921 | Chemiluminescence TSH 3RD Generation ImmunoassayJLW · Traditional | Nichols Institute Diagnostics | 05/02/1995SE |
| K943195 | Coat-A-Count Neonatal TSH IrmaJLW · Traditional | Diagnostic Products Corp. | 03/13/1995SE |
| K942658 | Neoscreen Elisa TSHJLW · Traditional | Pantex, Div. Bio-Analysis, Inc. | 02/24/1995SE |
| K942661 | Aqualite TSH Bioluminescent Immunoassay KitJLW · Traditional | Sealite Sciences, Inc. | 01/17/1995SE |
| K940006 | Immulite Third Generation (Modification)JLW · Traditional | Diagnostic Products Corp. | 12/19/1994SE |
| K935399 | Radias Neonatal TSH Enzyme ImmunoassayJLW · Traditional | Bio-Rad | 12/19/1994SE |
| K933212 | Immulite Rapid TSHJLW · Traditional | Diagnostic Products Corp. | 12/19/1994SE |
| K941146 | Dupont Aca Plus Thyroid Stimulating Hormone SystemJLW · Traditional | Dupont Medical Products | 10/03/1994SE |
| K935049 | Elegance Neonatal TSH ElisaJLW · Traditional | Bioclone Australia Pty , Ltd. | 10/03/1994SE |
| K942566 | Imx Ultrasensistive HTSH IIJLW · Traditional | Abbott Laboratories | 08/16/1994SE |
| K934410 | Axsym Ultrasensitive HTSHJLW · Traditional | Abbott Laboratories | 06/21/1994SE |
| K935119 | Radias 3RD Generation TSH ImmunoassayJLW · Traditional | Bio-Rad | 04/06/1994SE |
| K930776 | Cobas Core TSH EiaJLW · Traditional | Roche Diagnostic Systems, Inc. | 12/03/1993SE |
| K930006 | Autobead TSH Enzyme Immunoassay Reagent KitJLW · Traditional | Bio-Chem Laboratory Systems, Inc. | 09/09/1993SE |
| K930050 | Sia Thyroid Stimulating Hormone Elisa KitJLW · Traditional | Sigma Chemical Co. | 08/19/1993SE |
| K931061 | Radias TSH Enzyme ImmunoassayJLW · Traditional | Bio-Rad | 06/16/1993SE |
| K923532 | National Screening Institute Micro-Plate TSH AssayJLW · Traditional | Solarcare Technologies Corp,Inc. | 03/12/1993SE |
| K925637 | Access HTSH AssayJLW · Traditional | Bio-Rad Laboratories, Inc. | 03/01/1993SE |
| K925132 | Becton Dickinson Thyroid Stimulating Hormone SysteJLW · Traditional | Becton Dickinson Advanced Diagnostics | 12/28/1992SE |
| K923401 | Delfia HTSH Ultra KitJLW · Traditional | Wallac OY | 11/30/1992SE |
| K922701 | Du Pont Aca Plus Immunoassay System TSH MethodJLW · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/09/1992SE |
| K922138 | Vista Ultrasensitive HTSH AssayJLW · Traditional | Syva Co. | 07/21/1992SE |
| K922736 | Kodak Amerlite TSH-30 Ultrasensitive Standard SeraJLW · Traditional | Eastman Kodak Company | 07/10/1992SE |
| K921958 | Elisa Tube TSH TestJLW · Traditional | Bio Clinic Co. | 07/02/1992SE |
| K921700 | TSH Enzyme Immunoassay Test Kit Cat. No. KIF4093JLW · Traditional | Medix Biotech, Inc. | 06/29/1992SE |
| K921816 | Vitek Immun Assay Sys(Vidas) Thyroi Stim Hor AssayJLW · Traditional | Biomerieux Vitek, Inc. | 06/18/1992SE |
| K920856 | Ventrex Coated Tube High Sensit. TSH RadioimmunoasJLW · Traditional | Hycor Biomedical, Inc. | 03/26/1992SE |
| K920442 | Immuchem Tsh-Mw ElisaJLW · Traditional | Icn Biomedicals, Inc. | 03/18/1992SE |
| K915195 | Enzymun-Test TSHJLW · Traditional | Boehringer Mannheim Corp. | 02/14/1992SE |
| K914756 | Ultrasensitive TSH (U-Tsh) Enzyme Immuno Test KitJLW · Traditional | Medix Biotech, Inc. | 01/15/1992SE |
| K913963 | Immuchem Neonatal Tsh-Mp ElisaJLW · Traditional | Icn Biomedicals, Inc. | 12/13/1991SE |
| K912852 | Stratus(R) Ultra-Sensit HTSH Fluor Enzyme ImmunoJLW · Traditional | Baxter Healthcare Corp | 09/27/1991SE |
| K912583 | Magic Lite TSH (HS) ImmunoassayJLW · Traditional | Ciba Corning Diagnostics Corp. | 08/12/1991SE |
| K912324 | Neonatal TSH (125I) Immunoradiometric AssayJLW · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/20/1991SE |
| K912241 | Stratus(R) HTSH Fluormetric Enzyme ImmunoassayJLW · Traditional | Baxter Healthcare Corp | 06/20/1991SE |
| K910837 | Sri TSH Immunenzymetric AssayJLW · Traditional | Serono-Baker Diagnostics, Inc. | 05/24/1991SE |
| K910981 | Ciba Corning Acs TSH ImmunoassayJLW · Traditional | Ciba Corning Diagnostics Corp. | 04/30/1991SE |
| K910411 | Microzyme TSH Enzyme Immunoassay KitJLW · Traditional | Immunotech Corp. | 04/03/1991SE |
| K910256 | Eclipse Ica TSHJLW · Traditional | Biotope, Inc. | 02/22/1991SE |
| K905710 | Pharmacia Delfia Neonatal HTSH KitJLW · Traditional | Pharmacia, Inc. | 02/21/1991SE |
| K905769 | Immulite Hs-TshJLW · Traditional | Cirrus Diagnostics, Inc. | 01/31/1991SE |
| K905099 | Elegance TSH ElisaJLW · Traditional | Bioclone Australia Pty , Ltd. | 12/18/1990SE |
| K904666 | Amerlite TSH-60 Assay Product Code: Lan. 0008/2008JLW · Traditional | Amersham Corp. | 11/02/1990SE |
| K903725 | Ez-Bead TSH Enzyme Immunoassay KitJLW · Traditional | Immunotech Corp. | 10/26/1990SE |
| K903391 | Allegro Lite Thyroid Stimulating Hormone Chem. ImmJLW · Traditional | Nichols Institute | 10/12/1990SE |
| K903311 | Novapath TSH Enzyme ImmunoassayJLW · Traditional | Bio-Rad | 09/07/1990SE |
| K902753 | Imx Ultrasentitive HTSHJLW · Traditional | Abbott Mfg., Inc. | 07/10/1990SE |
| K902333 | Opus TSH Test SystemJLW · Traditional | Pb Diagnostic Systems, Inc. | 07/05/1990SE |
| K900277 | Enzymun Test(R) Tsh-SJLW · Traditional | Boehringer Mannheim Corp. | 04/11/1990SE |
| K897138 | Affinity(Tm) Htsh(Tm)JLW · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/09/1990SE |
| K896867 | Thyroid Stimulating Hormone-Eia-XtJLW · Traditional | In Vitro Diagnostics, Inc. | 02/23/1990SE |
| K900014 | Milenia (TM) TSHJLW · Traditional | Diagnostic Products Corp. | 01/19/1990SE |
| K895396 | Cyberfluor Fiagen TSHJLW · Traditional | Cyberfluor, Inc. | 10/31/1989SE |
| K890802 | Cotube(Tm) TSH IrmaJLW · Traditional | Bio-Rad | 03/28/1989SE |
| K890579 | TSH MicroassayJLW · Traditional | Diamedix Corp. | 03/16/1989SE |
| K885157 | Ventrex Coated Tube High Sensitivity TSHJLW · Traditional | Ventrex Laboratories, Inc. | 02/10/1989SE |
| K883742 | Modified TSH Irma KitJLW · Traditional | Pacific Biotech, Inc. | 01/03/1989SE |
| K883726 | Thyroid Stimulating Hormone (HTSH) Irma NeonatalJLW · Traditional | Immuchem Corp. | 12/15/1988SE |
| K881627 | Delfia(Tm) Neonatal HTSH KitJLW · Traditional | Pharmacia, Inc. | 10/03/1988SE |
| K882907 | Amerlite TSH Assay, LAN.0001/2001 240 & 144 KitJLW · Traditional | Amersham Corp. | 09/22/1988SE |
| K883342 | Ventrex Coated Tube TSHJLW · Traditional | Ventrex Laboratories, Inc. | 09/13/1988SE |
| K881381 | Reagents for TSH AssayJLW · Traditional | Sclavo, Inc. | 07/21/1988SE |
| K881443 | Lumatag(Tm) TSH Chemiluminescence Immuno. AssayJLW · Traditional | London Diagnostics, Inc. | 05/27/1988SE |
| K880086 | Abbott Imx HTSHJLW · Traditional | Abbott Laboratories | 04/05/1988SE |
| K874622 | Fiagen(Tm) HTSH Catalogue Number: 101-301JLW · Traditional | Cyberfluor, Inc. | 12/18/1987SE |
| K874061 | TSH Enzyme Immunoassay Test Kit No. MB-1093JLW · Traditional | Medix Biotech, Inc. | 11/03/1987SE |
| K873303 | Binax L.S. TSH Irma Test KitJLW · Traditional | Binax, Inc. | 10/02/1987SE |
| K872897 | TSH Serozyme Immunoenzymetric Kit, Mag. Solid Pha.JLW · Traditional | Serono Diagnostics, Inc. | 07/31/1987SE |
| K872305 | Irma-Count TSH RKTS1, RKTS2, RKTS5, RktsxJLW · Traditional | Diagnostic Products Corp. | 07/01/1987SE |
| K871505 | Autopak Neonatal TSH Monoclonal Irma KitJLW · Traditional | Micromedic Systems | 05/26/1987SE |
| K870904 | Micromedic Neonatal TSH Monoclonal Irma KitJLW · Traditional | Micromedic Systems | 05/26/1987SE |
| K871644 | Delfia (TM) HTSH KitJLW · Traditional | Lkb Instruments, Inc. | 05/12/1987SE |
| K870245 | Autopak TSH Monoclonal Irma KitJLW · Traditional | Micromedic Systems | 04/01/1987SE |
| K870244 | Iq TSH ImmunoassayJLW · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/01/1987SE |
| K870320 | Dacomed Penile Prosthesis SizerJLW · Traditional | Dacomed Corp. | 03/17/1987SE |
| K865071 | Thyroid Stimulating Hormone (TSH Irma) Ria KitJLW · Traditional | Immuchem Corp. | 03/13/1987SE |
| K865081 | Affinity(Tm) HTSH Immunit(Tm)JLW · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/12/1987SE |
| K864839 | TSH Mab IrmaJLW · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/04/1987SE |
| K864659 | Bio-Mega Diagnostic Coated Tube Irma TSHJLW · Traditional | Bio Mega Diagnostic, Inc. | 02/04/1987SE |
| K864677 | TSH Maiaclone Immunoradiometric Assay Kit/Mag SepJLW · Traditional | Serono Diagnostics, Inc. | 01/07/1987SE |
| K864133 | DSL-5300 TSH Immunoradiometric Assay (Irma) KitJLW · Traditional | Diagnostic Systems Laboratories, Inc. | 12/18/1986SE |
| K864134 | DSL-4800 Active TM TSH Eia SystemJLW · Traditional | Diagnostic Systems Laboratories, Inc. | 12/16/1986SE |
| K864079 | Ubi Magiwel(Tm) TSH QuantitativeJLW · Traditional | United Biotech, Inc. | 12/16/1986SE |
| K863859 | Tandem-M Immunoenzymetric Assay for Thyr/Stim/HormJLW · Traditional | Hybritech, Inc. | 11/21/1986SE |
| K862407 | Ciba Corning Magic Lite TSH ImmunoassayJLW · Traditional | Ciba Corning Diagnostics Corp. | 08/29/1986SE |
| K862428 | Stratus TSH Fluorometric Enzyme ImmunoassayJLW · Traditional | American Dade | 08/19/1986SE |
| K860813 | Micromedic HTSH Monoclonal Irma KitJLW · Traditional | Micromedic Systems | 07/14/1986SE |
| K861918 | V-Trend Eia TSHJLW · Traditional | V-Tech, Inc. | 07/02/1986SE |
| K862249 | TSH Irma KitJLW · Traditional | Pacific Biotech, Inc. | 06/27/1986SE |
| K861573 | Terumo Sensibead Eia TSH KitJLW · Traditional | Terumo Medical Corp. | 06/19/1986SE |
| K861920 | Simultrac Neonatal T4(57CO)/TSH(125I) Radioimmuno.JLW · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/16/1986SE |
| K860824 | Tshk-Nn Ria KitJLW · Traditional | Cis-Us, Inc. | 04/28/1986SE |
| K860288 | Echoclonal HTSH IrmaJLW · Traditional | Bio-Rad | 04/11/1986SE |
| K860054 | Tsh-Irma Coat-A-Count KitJLW · Traditional | Diagnostic Products Corp. | 03/17/1986SE |
| K854379 | Micro-Elisa TSH Test Kit-Visi-Check TSH Test KitJLW · Traditional | Bioclinical Systems, Inc. | 01/07/1986SE |
| K854087 | NML TSH IrmaJLW · Traditional | Organon Teknika Corp. | 10/25/1985SE |
| K853977 | Beta-Tsh-IrmaJLW · Traditional | Leeco Diagnostics, Inc. | 10/22/1985SE |
| K853717 | Allegro TM Hs-Tsh Immunoassay SystemJLW · Traditional | Nichols Institute Diagnostics | 10/02/1985SE |
| K852438 | NML TSH IrmaJLW · Traditional | Nuclear Medical Laboratories, Inc. | 07/12/1985SE |
| K852224 | Lee-Bead Tsh(Eia)JLW · Traditional | Lecco Diagnostics, Inc. | 07/09/1985SE |
| K851329 | Magic Monoclonal Antibody Tsh(Mab Tsh)RadioimmunoaJLW · Traditional | Corning Medical & Scientific | 06/13/1985SE |
| K851980 | Endab TSHJLW · Traditional | Immunotech Corp. | 05/31/1985SE |
| K851120 | Delfia HTSH KitJLW · Traditional | Lkb Instruments, Inc. | 05/31/1985SE |
| K851148 | TSH IRMA(125I) Btsi 1(THYROID Stimula-HormoneJLW · Traditional | Euro-Diagnostics BV | 04/29/1985SE |
| K844583 | Tsh-StatJLW · Traditional | Nuclear Medical Laboratories, Inc. | 03/05/1985SE |
| K850376 | Terumo Sensibead Eia TSH KitJLW · Traditional | Terumo Medical Corp. | 03/04/1985SE |
| K843540 | Abbott HTSH Eia Diagnostic KitJLW · Traditional | Abbott Laboratories | 11/02/1984SE |
| K843395 | Encore TSH ReagentJLW · Traditional | Hybritech, Inc. | 10/11/1984SE |
| K843545 | TSH Quik Ria KitJLW · Traditional | Pacific Biotech, Inc. | 10/02/1984SE |
| K843281 | Accuscreen TSHJLW · Traditional | Neometrics, Inc. | 09/26/1984SE |
| K842593 | Sucrosep Thyroid Stimulating HormoneJLW · Traditional | Boots-Celltech Diagnostics, Inc. | 09/12/1984SE |
| K842948 | Amerlex-M TSH RiaJLW · Traditional | Amersham Corp. | 09/04/1984SE |
| K841606 | Blood Spot Neonatal TSH RadioimmunoJLW · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/22/1984SE |
| K840088 | Biodex Act-O-Kit Tsh-Ria-JLW · Traditional | Biodan Medical Systems, Ltd. | 05/07/1984SE |
| K833193 | Radioimmunoassay, Thyroid Stimu. HormoneJLW · Traditional | Biosan Laboratories, Inc. | 02/04/1984SE |
| K833713 | Serum Thyrotropin Assay Kit, Tipsep-JLW · Traditional | Nuclear Diagnostics, Inc. | 12/29/1983SE |
| K832813 | Tandem-E Thyroid Stimulating Hormone KitJLW · Traditional | Hybritech, Inc. | 10/31/1983SE |
| K832823 | Enzymune-Test TSHJLW · Traditional | Icl Scientific | 10/14/1983SE |
| K831972 | Epsilon TSH Test KitJLW · Traditional | Beckman Instruments, Inc. | 09/20/1983SE |
| K832499 | Phase II TSH KitJLW · Traditional | Medical & Scientific Designs, Inc. | 09/12/1983SE |
| K832462 | Autopak Neonatal TSH Ria KitJLW · Traditional | Micromedic Systems | 09/12/1983SE |
| K832313 | Magic TSH 125I RadioimmunoassayJLW · Traditional | Corning Medical & Scientific | 09/01/1983SE |
| K830928 | Ventrex Enzyme TSH KitJLW · Traditional | Ventrex Laboratories, Inc. | 04/28/1983SE |
| K830036 | Neonatal NTSH Radioimmunoassay SysJLW · Traditional | Corning Medical & Scientific | 01/28/1983SE |
| K823688 | Double Antibody TSH I-125 RadioimmunoJLW · Traditional | Corning Medical & Scientific | 01/05/1983SE |
| K822935 | Thyroid Stimulating HormoneJLW · Traditional | Pcl-Ria, Inc. | 11/01/1982SE |
| K822827 | Hish Eia Diagnostic KitJLW · Traditional | Abbott Laboratories | 10/27/1982SE |
| K822705 | Tamdem-R Thyroid Stimulating Hormone KitJLW · Traditional | Hybritech, Inc. | 10/13/1982SE |
| K822291 | Quantimune HTSH IrmaJLW · Traditional | Bio-Rad | 08/27/1982SE |
| K821620 | (125I) HTSH Radioimmunoassay KitJLW · Traditional | Yang Laboratories, Inc. | 06/14/1982SE |
| K821174 | Tsh-Squibb Radioimmunoassay KitJLW · Traditional | Squibb & Sons, Inc. | 05/14/1982SE |
| K820089 | TSH (Ria) KitJLW · Traditional | Immuno Assay Corp. | 01/28/1982SE |
| K813645 | Micromedic HTSH Ria KitJLW · Traditional | Micromedic Systems | 01/22/1982SE |
| K813525 | In Vitro Diagnostic RadioimmunoassayJLW · Traditional | Micromedic Systems | 12/31/1981SE |
| K813392 | Radioimmunoassay for Human ThyroidJLW · Traditional | Leeco Diagnostics, Inc. | 12/22/1981SE |
| K812136 | Amerlex TSH Ria KitJLW · Traditional | Amersham Corp. | 08/13/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0752-2026 Class II | Thyroid TSH TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0216-2026 Class II | DxI 9000 Access Immunoassay Analyzer, Part Number C11137Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i… | Beckman Coulter, Inc. | 09/19/2025Open, Classified |
| Z-1926-2025 Class II | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions…A new motor/encoder and cable was introduced into instruments manufactured starting with serial number… | Beckman Coulter, Inc. | 04/23/2025Open, Classified |
| Z-1913-2025 Class II | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from… | Beckman Coulter, Inc. | 04/23/2025Open, Classified |
| Z-0094-2025 Class II | The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay…Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone)… | Beckman Coulter, Inc. | 08/28/2024Open, Classified |
| Z-0022-2025 Class II | FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP…Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information… | Qualigen Inc | 08/26/2024Open, Classified |
| Z-1253-2022 Class II | Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro…Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous… | Siemens Healthcare Diagnostics, Inc. | 04/13/2022Open, Classified |
| Z-1252-2022 Class II | Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro…Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous… | Siemens Healthcare Diagnostics, Inc. | 04/13/2022Open, Classified |
| Z-2028-2021 Class II | Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of…Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a… | Siemens Healthcare Diagnostics, Inc. | 05/13/2021Open, Classified |
| Z-2027-2021 Class II | Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of…Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a… | Siemens Healthcare Diagnostics, Inc. | 05/13/2021Open, Classified |
| Z-0474-2021 Class II | Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to…Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for… | Siemens Healthcare Diagnostics, Inc. | 10/26/2020Terminated |
| Z-0473-2021 Class II | Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to…Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a… | Siemens Healthcare Diagnostics, Inc. | 10/26/2020Terminated |
| Z-0044-2020 Class II | AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c…AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal… | Roche Diagnostics Operations, Inc. | 08/13/2019Terminated |
| Z-1300-2019 Class II | Atellica IM 1600 Analyzer, Material Number 11066000There were multiple issues identified in the system software which required an update. | Siemens Healthcare Diagnostics, Inc. | 03/07/2019Terminated |
| Z-1299-2019 Class II | Atellica IM 1300 Analyzer, Material Number 11066001There were multiple issues identified in the system software which required an update. | Siemens Healthcare Diagnostics, Inc. | 03/07/2019Terminated |
| Z-0664-2019 Class II | Alinity i TSH Reagent Kit, List Number 07P4830Abbott 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-0080-2019 Class II | VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative…Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide… | Ortho-Clinical Diagnostics | 08/15/2018Terminated |
| Z-0079-2019 Class II | VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative…Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide… | Ortho-Clinical Diagnostics | 08/15/2018Terminated |
| Z-0061-2019 Class II | VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products… | Ortho Clinical Diagnostics Inc | 07/12/2018Open, Classified |
| Z-2077-2018 Class II | AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, ThyroidAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-1322-2018 Class III | VITROS Immunodiagnostic Products TSH Reagent PackVITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some… | Clinical Diagnostic Systems | 01/11/2018Terminated |
| Z-1673-2018 Class II | Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridgeThe concentrations for biotin listed in the non-interfering substances section of the instructions for use… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-1668-2018 Class II | Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridgeThe concentrations for biotin listed in the non-interfering substances section of the instructions for use… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-2054-2018 Class II | ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers:…In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution… | Siemens Healthcare Diagnostics, Inc. | 12/18/2017Open, Classified |
| Z-2611-2017 Class II | Dimension Vista Thyroid Stimulating Hormone (TSH) 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-2580-2016 Class III | VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191…A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected… | Ortho-Clinical Diagnostics | 07/28/2016Terminated |
| Z-2256-2016 Class II | ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2…Eight (8) issues were identified which may affect the results generated by the system software version. | Siemens Healthcare Diagnostics, Inc. | 05/26/2016Terminated |
| Z-0072-2017 Class II | ADVIA Centaur XPT Immunoassay SystemThe ADVIA Centaur XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency… | Siemens Healthcare Diagnostics, Inc. | 04/28/2016Terminated |
| Z-1708-2015 Class II | Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro…Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results… | Siemens Healthcare Diagnostics, Inc. | 04/20/2015Terminated |
| Z-1655-2014 Class II | ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material…Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D… | Siemens Healthcare Diagnostics, Inc | 04/10/2014Terminated |
| Z-1654-2014 Class II | ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080…Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D… | Siemens Healthcare Diagnostics, Inc | 04/10/2014Terminated |
| Z-1653-2014 Class II | ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens…Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D… | Siemens Healthcare Diagnostics, Inc | 04/10/2014Terminated |
| Z-1886-2013 Class II | IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 -…A rare variant of TSH, identified in a small cluster of patients, is not detected. | Siemens Healthcare Diagnostics, Inc | 05/10/2013Terminated |
| Z-1885-2013 Class II | IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T…A rare variant of TSH, identified in a small cluster of patients, is not detected. | Siemens Healthcare Diagnostics, Inc | 05/10/2013Terminated |
| Z-1884-2013 Class II | Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to…A rare variant of TSH, identified in a small cluster of patients, is not detected. | Siemens Healthcare Diagnostics, Inc | 05/10/2013Terminated |
| Z-1883-2013 Class II | Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to…A rare variant of TSH, identified in a small cluster of patients, is not detected. | Siemens Healthcare Diagnostics, Inc | 05/10/2013Terminated |
| Z-1882-2013 Class II | Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure…A rare variant of TSH, identified in a small cluster of patients, is not detected. | Siemens Healthcare Diagnostics, Inc | 05/10/2013Terminated |
| Z-1881-2013 Class II | ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 -…A rare variant of TSH, identified in a small cluster of patients, is not detected. | Siemens Healthcare Diagnostics, Inc | 05/10/2013Terminated |
| Z-0648-2013 Class III | Immunoradiometric assay. Device is an immunoradiometric assay designed for the…The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values… | Siemens Healthcare Diagnostics | 11/28/2012Terminated |
| Z-0647-2013 Class III | Immunoradiometric assay.The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values… | Siemens Healthcare Diagnostics | 11/28/2012Terminated |
| Z-0646-2013 Class III | Immunoradiometric assay. Device is an immunoradiometric assay designed for the…The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values… | Siemens Healthcare Diagnostics | 11/28/2012Terminated |
| Z-2121-2012 Class II | Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage:…Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic… | Perkinelmer | 06/27/2012Terminated |
| Z-0603-2012 | The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high…Malfunction of the GSP disk remover unit may cause a punched disc to remain in the well during the… | PerkinElmer LAS, Inc | 10/24/2011Terminated |
| Z-0459-2011 | The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by…Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high… | Siemens Healthcare Diagnostics, Inc. | 04/12/2010Terminated |
| Z-0646-2007 | Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.Positive control showed little or no positive line. | ThyroTec Inc | 01/24/2007Terminated |