Device Recall VITROS Immunodiagnostic Products CA 199 Reagent Pack and CA 199 Calibrators

  • Modèle / numéro de série
    Lot 1320, Product code: 6800035 and 6800040
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to France and Japan
  • Description du dispositif
    VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 || VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    ORTHO-CLINICAL DIAGNOSTICS, FELINDRE MEADOWS, Bridgend United Kingdom
  • Société-mère du fabricant (2017)
  • Source
    USFDA