Device Recall BioRad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set

  • Modèle / numéro de série
    Medical device, intended for percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography, intended for professional use only.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed to 127 customers throughout the US and internationally to Argentina, Australia, Canada, Chile, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, New Zealand, Poland, Singapore, Sweden, Taiwan, and the United Kingdom
  • Description du dispositif
    Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA