Devices

Device Recall HITACHI DIRECT AND HITACHI TOTAL BILIRUBIN REAGENT

  • Modèle / numéro de série
    HB936-120, Lot Number: 731801, exp. 11/2011 and HB936-294, Lot Number: 817103, exp. 5/2012.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Chile and Mexico.
  • Description du dispositif
    Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. || The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers.
  • Manufacturer
    Pointe Scientific, Inc.
  • 1 Event

Fabricant

Pointe Scientific, Inc.
  • Adresse du fabricant
    Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188
  • Société-mère du fabricant (2017)
    MedTest Holdings
  • Source
    USFDA