System, Test, Thyroglobulin
FDA product code MSW · Class II (moderate risk) · 21 CFR 866.6010 · Immunology
13510(k) clearances
0PMA approvals
10recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242981 | Atellica IM Thyroglobulin (Tg)MSW · Traditional | Siemens Healthcare Diagnostics, Inc. | 06/20/2025SE |
| K240927 | Access ThyroglobulinMSW · Traditional | Beckman Coulter, Inc. | 06/28/2024SE |
| K241423 | Access ThyroglobulinMSW · Traditional | Beckman Coulter, Inc. | 06/07/2024SE |
| K221890 | Elecsys Tg IIMSW · Traditional | Roche Diagnostics | 09/30/2023SE |
| K220972 | Access ThyroglobulinMSW · Traditional | Beckman Coulter, Inc. | 09/15/2023SE |
| K031269 | Access Thyroglobulin Reagents on the Access Immunoassay SystemsMSW · Special | Beckman Coulter, Inc. | 05/02/2003SE |
| K021057 | Brahms Diagnostica Dynotest Tg-PlusMSW · Traditional | Brahms Diagnostica, LLC | 09/17/2002SE |
| K002888 | Nichols Advantage ThyroglobMSW · Traditional | Nichols Institute Diagnostics | 10/20/2000SE |
| K002905 | Access Thyroglobulin Reagents on the Access AnalyzerMSW · Traditional | Beckman Coulter, Inc. | 10/19/2000SE |
| K994140 | Nichols Chemiluminescence Thyroglobulin, Model 60-4240MSW · Traditional | Nichols Institute Diagnostics | 05/09/2000SE |
| K991720 | Kronus Optiquant Thyroglobulin KitMSW · Traditional | Unchanged | 08/09/1999SE |
| K982468 | Immulite 2000 Thyroglobulin Model L2KTYMSW · Traditional | Diagnostic Products Corp. | 03/12/1999SE |
| K982466 | Immulite Thyroglobulin Model LktyMSW · Traditional | Diagnostic Products Corp. | 03/12/1999SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2322-2025 Class II | Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog…Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased… | Beckman Coulter, Inc. | 07/10/2025Open, Classified |
| Z-0100-2024 Class II | Access Thyroglobulin CalibratorsIt has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator… | Beckman Coulter, Inc. | 07/06/2023Open, Classified |
| Z-0950-2023 Class II | IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000…Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots… | Siemens Healthcare Diagnostics, Inc. | 12/07/2022Open, Classified |
| Z-0949-2023 Class II | IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000…Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots… | Siemens Healthcare Diagnostics, Inc. | 12/07/2022Open, Classified |
| Z-2240-2020 Class II | Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI:…The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all… | Beckman Coulter Inc. | 04/30/2019Terminated |
| Z-1685-2018 Class II | IMMULITE 2000/IMMULITE 2000 XPi TGConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-1684-2018 Class II | IMMULITE /IMMULITE 1000 TGConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-2636-2017 Class II | Access Thyroglobulin, A34085G, Catalog No. 33860The Access immunoassays are susceptible to biotin interference. | Beckman Coulter Inc. | 05/09/2017Terminated |
| Z-2733-2015 Class II | Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the…Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit greater than… | Beckman Coulter Inc. | 07/28/2015Terminated |
| Z-2215-2011 | Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is intended to…The recall was initiated because In addition to Access Tg Sample Diluent, an additional diluent, Access Wash… | Beckman Coulter Inc. | 10/18/2010Terminated |