Device Recall Piccolo Comprehensive Metabolic Panel

  • Modèle / numéro de série
    Lot Number: 0396BC5  Boxes # 686 - 834 and # 665-685.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and countries of: Kowloon and Germany.
  • Description du dispositif
    Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 400-0028; || Product is manufactured and distributed by Abaxis, Incorporated, || Union City, CA || The Piccolo Comprehensive Metabolic Reagent Disc, used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma or serum. The patented self¿contained reagent rotors are bar coded, contain liquid diluents and dry reagents and use centrifugal and capillary technology to provide the most commonly requested chemistry panel results in approximately 12 minutes. The Piccolo Comprehensive Metabolic Panel, used with the Piccolo Blood Chemistry Analyzer is a diagnostic system that aids in disease diagnosis or monitoring disease treatment.
  • Manufacturer
  • 1 Event

Fabricant

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