Device Recall ADVIA Centaur CA199 Assay

  • Modèle / numéro de série
    Reagent Lot # Expiry Date XXXXX294 11-Aug-11 XXXXX296 6-Oct-11 XXXXX298 6-Nov-11 XXXXX299 6-Nov-11 XXXXX302 9-Jan-12 XXXXX303 9-Jan-12 XXXXX305 18-Feb-12 XXXXX306 3-Apr-12 XXXXX307 3-Apr-12 XXXXX308 3-Apr-12 XXXXX309 3-Jun-12 XXXXX311 30-Jun-12
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of Australia, Malyasia, Korea, Hong Kong, Singapore, Myanmar, Mexico, Egypt, Taiwan, South Africa, Brazil ,India, Japan, Argentina, Chile, Peru, Germany, Malaysia, Saudi Arabia, and Canada.
  • Description du dispositif
    ADVIA Centaur CA19-9 Assay || Cat. Nos. || 123521 (03481938) - 250 Test kit w/o Calibrators || 123519 (04612750) - 50 Test kit w/o Calibrators || 10491244 - 250 Test kit w/Calibrators || 10491379 - 50 Test kit w/Calibrators || The ADVIA Centaur CA 19-9 Assay is an¿ in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined.
  • 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