Device Recall Triage Total Controls 5, Level 1

  • Modelo / Serial
    Model 88753 Lots C1916A, C1931A, C1932A & C1999A
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution
  • Descripción del producto
    Triage Total Controls 5, Level 1: Five 0.25 mL tubes. Storage Temp <-20C. || Intended use: Assayed materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Triage D-Dimer Test and Triage Meters to assist in monitoring test performance.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Biosite Inc, 9975 Summers Ridge Rd, San Diego CA 92121
  • 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.
  • Source
    USFDA