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IMMULITE® 2000 Systems RTH Rapid TSH
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Model 10381651 · UDI-DI 00630414962016
1
510(k) clearances
2,771
Adverse events
46
Recalls
69
Facilities
Description
TSH - IMMULITE - RGT - 200 Tests
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 of user-specified m |
| 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 generated, and may require |
| 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 introducing error codes fo |
| 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 the TSH results obtain |
| 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 the valve wearing and |
| 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 the valve wearing and |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.