Device Recall PICCOLO(TM)

  • Modèle / numéro de série
    Lot number 9284AC2, accidentally labeled as 9285AC2, catalog number 400-0028, expiration date 7/9/2010
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and Canada, EU and Asia
  • Description du dispositif
    Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufactured by Abaxis Inc., Union City, CA || Medical device for use in the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline Phosphatase (ALP), aspartate aminotransferase, calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen in heparinized whole blood, heparinized plasma or serum.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Abaxis Inc, 3240 Whipple Rd, Union City CA 94587
  • Société-mère du fabricant (2017)
  • Source
    USFDA