FDAFDA · Alimentos y medicamentos·N.º oficial Z-0094-2025
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results. The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Publicado el 23 de octubre de 2024 · Inicio del retiro: 28 de agosto de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Beckman Coulter, Inc.
- Distribuidor
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Croatia, France, Germany, Ireland, Italy, Slovakia, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.
- Lote
- UDI/DI 15099590744373, Lot Numbers: 339117, 338724, 439341, 338367, 338057, 234251
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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