Devices

Device Recall SPOTCHEM II Basic Panel test strips

  • Modèle / numéro de série
    Lot Number PN5C26
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.
  • Description du dispositif
    arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. || For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.
  • Manufacturer
    Arkray Factory USA, Inc.
  • 1 Event

Fabricant

Arkray Factory USA, Inc.
  • Adresse du fabricant
    Arkray Factory USA, Inc., 5182 W 76th St, Minneapolis MN 55439-2900
  • Société-mère du fabricant (2017)
    Arkray Global Business Inc.
  • Source
    USFDA