Device Recall Dimension Vista/Blood Urea Nitrogen Flex/BUN

  • Modelo / Serial
    Device Listing # D011374, Lot # 15341AC, 15320BB, 15300BA, 15299BB, 15264BA, 15243BB and 15215AE
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - US (nationwide) distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. , and to the countries of : Canada, United Arab Emir, Australia, Austria, Belgium, Switzerland, Bahamas, Czech Republic, Germany, Denmark, Spain, Finland, France, Italy, Netherland, Norway, Portugal, Slovakia, Slovenia, Japan, Republic of Korea, New Zealand.
  • Descripción del producto
    Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge || The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA