Device Recall Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS)

  • Modèle / numéro de série
    Lot Number 15243MA Mfg Date: 08/31/2015 Exp Date: 05/31/2016 Lot Number 15243MB Mfg Datge: 08/31/2015 Exp Date: 05/31/2016
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to: AL, AR, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI, WV
  • Description du dispositif
    Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    CSL Behring GmbH, Emil-von-Behring-Str. 76, Marburg Germany
  • Société-mère du fabricant (2017)
  • Source
    USFDA