Device Recall A1CNOW

  • Modelo / Serial
    Model Number 03022-Lot Numbers 0707812, 0707813, 0707814, and 0707815.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide including states of AK, AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MN, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and Puerto Rico.
  • Descripción del producto
    A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA 94085. (This test provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is used by professional healthcare providers to monitor long-term glycemic control in people with diabetes. The product is sold as a kit with a disposable monitor and reagents for ten A1C tests and is suitable for use at the point-of-care.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Metrika Inc, 510 Oakmead Pkwy, Sunnyvale CA 94085-4022
  • Source
    USFDA