Device Recall ProbeChek UroVysion Control Slides

  • Modelo / Serial
    catalog #30-805070, lot 47228, exp. 05/04 and lot 49023, exp. 08/04
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    Vysis, 3100 Woodcreek Dr, Downers Grove IL 60515-5427
  • Source
    USFDA