Devices

Device Recall Contour Next Control Solution for Contour Next Blood Glucose Test System

  • Modèle / numéro de série
    SKU# 7314 (Level 2) and SKU# 7315 (Level 1) All Lots
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Switzerland, UK, Albania, Azerbaijan, Bulgaria, Czech Republic, Estonia, Hungary, Korea, Latvia, Lithuania, Philippines, Romania, Serbia, Slovakia, and Thailand.
  • Description du dispositif
    Contour Next Control Solution for Contour Next Blood Glucose Test System. || Liquid quality control solution. Plastic bottle, 2.5mL. || Indicated for use with fresh fingertip capillary whole blood samples.
  • Manufacturer
    Bayer Healthcare, LLC
  • 1 Event

Fabricant

Bayer Healthcare, LLC
  • Adresse du fabricant
    Bayer Healthcare, LLC, 430 S Beiger St, Mishawaka IN 46544-3207
  • Société-mère du fabricant (2017)
    Bayer AG
  • Source
    USFDA