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Elecsys Tg II

Roche Diagnostics GmbH · Model 08906556160 · UDI-DI 07613336203569

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510(k) clearances

Adverse events

Recalls

Facilities

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 pursue unnecessary dia
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 distributed in April 2023 will
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; when control results
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; when control results
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 (Free T3-REF A13422
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 MMB, Dimension Sirol
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 MMB, Dimension Sirol
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 for use (IFU) for ev

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Data 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.