Home › Device types › JLW
Radioimmunoassay, Thyroid-Stimulating Hormone
FDA product code JLW · Class 2 · Clinical Chemistry
131
Registered devices
2,788
Adverse events
46
Recalls
242
510(k) clearances
Devices with this code
QMedix™ — Diagnostic Automation, Inc.TSH Rapid AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.VIDAS® TSH — BIOMERIEUX SADimension® EXL™/ Dimension Vista® MULTI 2 SDIL — Siemens Healthcare Diagnostics Inc.Monobind AccuBind TSH Rapid ELISA Kit - 96 Wells — MONOBIND, INC.MAGLUMI 2000 TSH — Shenzhen New Industries Biomedical Engineering Co., Ltd.AFIAS TSH-SP — Boditech Med Inc.Free T3, Free T4, TSH Thyroid Panel AccuBind VAST ELISA Test System - 960 Wells — MONOBIND, INC.AFIAS-6/SP Analyzer — Boditech Med Inc.Dimension® EXL™ LOCI® Module Flex® reagent cartridge TSHL — Siemens Healthcare Diagnostics Inc.AutoDELFIA Neonatal hTSH kit — Wallac OyNeonatal TSH Elisa — MP BIOMEDICALS, LLCAccess TSH (3rd IS) — Beckman Coulter, Inc.Thyroid Stimulating Hormone (TSH) ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDVITROS — ORTHO CLINICAL DIAGNOSTICSADVIA Centaur® TSH3-UL — Siemens Healthcare Diagnostics Inc.DELFIA Neonatal hTSH kit — Wallac OyN-TSH AccuBind ELISA Test System - 1920 Wells — MONOBIND, INC.ARCHITECT — ABBOTT IRELANDTSH AccuLite CLIA Test System - 480 Wells — MONOBIND, INC.ADVIA Centaur® TSH — Siemens Healthcare Diagnostics Inc.ADVIA Centaur TSH3-Ultra II — Siemens Healthcare Diagnostics Inc.Atellica IM TSH3-UL — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-09-19 | Beckman Coulter, Inc. | Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application |
| 2025-04-23 | Beckman Coulter, Inc. | A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introd |
| 2025-04-23 | Beckman Coulter, Inc. | A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being genera |
| 2024-08-28 | Beckman Coulter, Inc. | Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results. |
| 2024-08-26 | Qualigen Inc | Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but th |
| 2022-04-13 | Siemens Healthcare Diagnostics, Inc. | Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results |
| 2022-04-13 | Siemens Healthcare Diagnostics, Inc. | Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results |
| 2021-05-13 | Siemens Healthcare Diagnostics, Inc. | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in th |
| 2021-05-13 | Siemens Healthcare Diagnostics, Inc. | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in th |
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