Device Recall Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges

  • Modelo / Serial
    Catalog number K1270 - lot numbers 09224AA, 09286AA, 09350AC, 10011AF, 10047AA, 10089AC, 10089AD, 10131AC and 10131AD.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution - including AL, AZ, CA, CO, DE, FL, GA, ID, IL, IA, MD, MA, MI, MT, NH, NJ, NY, NC, OH, OR, PA, SC, TX, VA, WA, and WI.
  • Descripción del producto
    Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System || The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.
  • 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