Device Recall Dimension Vista(R) VANC Flex(R) Reagent Cartridge

  • Modèle / numéro de série
    lot 12095AD, exp 2013-04-04
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, including Washington, DC and the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WV, and the countries of Canada, New Zealand, Germany, and Puerto Rico.
  • Description du dispositif
    Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). || For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Société-mère du fabricant (2017)
  • Source
    USFDA