Home › Device types › MSW
System, Test, Thyroglobulin
FDA product code MSW · Class 2 · Immunology
20
Registered devices
86
Adverse events
10
Recalls
13
510(k) clearances
Devices with this code
Monobind AccuLite Tg CLIA Kit - 96 Wells — MONOBIND, INC.IMMULITE® Systems GAS CONTROL Gastrin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDTg AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.IMMULITE® 2000 Systems TG Thyroglobulin Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAtellica IM Tg — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDTg AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.B.R.A.H.M.S Tg-pluS RIA — B.R.A.H.M.S GmbHAccess Thyroglobulin Calibrators — Beckman Coulter, Inc.Access Thyroglobulin Sample Diluent — Beckman Coulter, Inc.Tg AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.Elecsys Tg II — Roche Diagnostics GmbHIMMULITE®/IMMULITE® 1000 Systems TG Thyroglobulin Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAccess Thyroglobulin — Beckman Coulter, Inc.IMMULITE®/IMMULITE® 1000 Systems TG Thyroglobulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE® 2000 Systems TG Thyroglobulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAccess Thyroglobulin — Beckman Coulter, Inc.Atellica IM Tg — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDElecsys Tg II — Roche Diagnostics GmbHIMMULITE® Systems TG Recovery Sample Thyroglobulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE® Systems TG CONTROL Thyroglobulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-10 | Beckman Coulter, Inc. | Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pu |
| 2023-07-06 | Beckman Coulter, Inc. | It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distribute |
| 2022-12-07 | Siemens Healthcare Diagnostics, Inc. | Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; |
| 2022-12-07 | Siemens Healthcare Diagnostics, Inc. | Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; |
| 2019-04-30 | Beckman Coulter Inc. | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays |
| 2018-01-02 | Siemens Healthcare Diagnostics, Inc. | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista |
| 2018-01-02 | Siemens Healthcare Diagnostics, Inc. | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista |
| 2017-05-09 | Beckman Coulter Inc. | The Access immunoassays are susceptible to biotin interference. |
| 2015-07-28 | Beckman Coulter Inc. | Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/mL. |
| 2010-10-18 | Beckman Coulter Inc. | The recall was initiated because In addition to Access Tg Sample Diluent, an additional diluent, Access Wash Buffer II, was added to Thyroglobulin instructions |
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