ARCHITECT Intact PTH assay

  • Modelo / Serial
    ARCHITECT Intact PTH Assay List Number 8K25 (see attached for impacted lots) Reagents (8K25-20, 8K25-25, 8K25-27), Calibrators (8K25-01) and Controls (8K25-10). More information on the affected products is provided in the attached letter
  • Descripción del producto
    ARCHITECT Intact PTH assay reagent and calibrator
  • Manufacturer
  • 1 Event

Fabricante

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Representante del fabricante
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA

6 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
  • Descripción del producto
    In-vitro diagnostics - immunological products
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott Laboratories ARCHITECT Intact PTH Assay
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    ARCHITECT Intact PTH Assay, Reagents (8K25-20, 8K25-25, 8K25-27), Calibrators (8K25-01) and Controls (8K25-10)
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    ARCHITECT Intact PTH Assay Reagents, Calibrators and Controls
  • Manufacturer
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