Device Recall Alere Triage CardioProfiler Panel PN 97100CP

  • Modelo / Serial
    Phase 1:  W49604B, W49606B, W49607B, W49611B, W49612B, W49613B, W49614B, W49615B, W49616B, W49617B, W49620B, W49622B, W49623B, W49624B, W49625B, W49627B, W49628B, W49629B, W49630B, W49631B, W49633B, W49634B, W49635B, W49638B, W49639B, W50726B, W50727B, W50728B, W50731B, W50733B, W50734B, W50738B, and W50739B.  Phase 2:  W49609B, W49610B, W49618B, W49619B, W49626B, W49632B, W49640B, W50737B, and W50744B.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Alere Triage CardioProfiler Panel PN 97100CP || Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 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