Device Recall Alere Triage Cardiac Panel PN 97000HS

  • Modèle / numéro de série
    Phase 1:  K50514B, W49753B, W49754B, W49756B, W49757B, W49758B, W49760B, W49761B, W49762B, W49764B, W49767B, W49768B, W49769B, W49770B, W50608B, W50613B, W50621B, W50623B, W50625B, W50632B, W50634B, W50637B, W50639B, W50641B, W50642B, W51114B, and W51119B.   Phase 2:  W49766B, W50605B, W50627B, W50628B, and W50629B.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Alere Triage Cardiac Panel PN 97000HS || Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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