10,000 results
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77ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCESS THYROGLOBULIN
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code JNL·June 7, 2021
UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code JNL·June 13, 2012
IMMULITE® 2000 THYROGLOBULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code JNL·May 27, 2022
ACCESS THYROGLOBULIN ANTIBODY II REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JNL·July 30, 2015
ACCESS THYROGLOBULIN
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code JNL·August 12, 2025
IMMULITE 2000
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JNL·August 26, 2009
ACCESS THYROGLOBULIN ANTIBODY II
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JNL·May 2, 2011
IMMULITE® 2000 THYROGLOBULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code JNL·December 8, 2022
IMMULITE® 2000 THYROGLOBULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code JNL·December 8, 2022
IMMULITE® 2000 THYROGLOBULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code JNL·December 8, 2022
IMMULITE® 2000 THYROGLOBULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code JNL·December 8, 2022
IMMULITE® 2000 THYROGLOBULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code JNL·December 8, 2022
IMMULITE® 2000 THYROGLOBULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code JNL·December 8, 2022
IMMULITE® 2000 THYROGLOBULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code JNL·December 8, 2022
ACCESS THYROGLOBULIN ANTIBODY II REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JNL·May 12, 2015
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code JNL·September 5, 2024
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JNL·April 30, 2019
Beckman Coulter Access Thyroglobulin Antibody II Reagent, Part Number: A32898. The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JNL·June 29, 2010
Access Thyroglobulin Antibody II, Part Number: A32898 The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JNL·January 26, 2011
Immunochemical, Thyroglobulin Autoantibody
FDA classification
FDA Class 2
·Immunochemical, Thyroglobulin Autoantibody