Device Recall Dimension(R) Creatinine Flex(R) Reagent Cartridges

  • Modelo / Serial
    Catalog number DF33A and lot numbers GA2196, GA2203, DC2221, DB2221, GA2229 and FA2237.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the District of Columbia and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Benin, Bosnia Herzegovina, Botswana, Brazil, Canada, Canary Islands, Ceuta/Mililla, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Fiji, France, French Guinea, Germany, Great Britian, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxemburg, Macedonia, Mexico, Montenegro, Morocco, Nepal, Nether Antilles, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam, Yemen and Zimbabwe.
  • Descripción del producto
    Dimension(R) Creatinine Flex(R) Reagent Cartridges. || The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista System.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Catalog Number DF33A - Lots BB1286, CA1260 and FB1251
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: United States and the following foreign countries: Austria, Belgium, Bosnia and Herzegovina, Canary Islands, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Great Britain, Greece, Hungary, Italy, Latvia, Lithuania, Kuwait, Macedonia, Morocco, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey and the United Arab Emirates.
  • Descripción del producto
    Dimension(R) Creatinine Flex(R) Reagent Cartridges || The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista System.
  • Manufacturer