Device Recall ProbeChek UroVysion Control Slides

  • Modèle / numéro de série
    catalog #30-805070, lot 47228, exp. 05/04 and lot 49023, exp. 08/04
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    DOmestically to accounts in Michigan, South Carolina, Illinois, Ohio, Connecticut, Arizona, New York, Texas, California, Oklahoma, Maryland, Virginia, Utah, Florida, Louisiana, Montana, Arkansas, Massachusetts, Minnesota, Missouri and North Carolina, and internationally to Germany and Japan.
  • Description du dispositif
    ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion Bladder Recurrence Kit; an invitro diagnostic; fixed, cultured normal human male lymphoblast cell line (negative target) and fixed culture human bladder carcinoma cell line specimens (positive), applied to glass microscope slides; catalog #30-805070, 3 slides per kit; Vysis, Inc., Downers Grove, IL 60515 USA
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Vysis, 3100 Woodcreek Dr, Downers Grove IL 60515-5427
  • Source
    USFDA