Device Recall Siemens Healthcare BR Assay for CA 27.29

  • Modèle / numéro de série
    All lot codes
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to the following countries: Argentina Australia Austria Azerbaijan Belgium Bosnia Herzeg. Brazil Canada Chile COLOMBIA Croatia Czech Republic Denmark Egypt Estonia Finland France Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Italy Japan Kazakhstan Latvia Lithuania Malaysia Mexico Netherlands New Caledonia Norway Oman P.R. China Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Reunion Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay Vietnam
  • Description du dispositif
    Siemens Healthcare BR Assay for CA 27.29 || 250 Test Kits 03896216 || 50 Test Kit 02419937 || Ref Kit (US only) 10340081 || Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Société-mère du fabricant (2017)
  • Source
    USFDA