Device Recall epoc BGEM Test Card

  • Modelo / Serial
    LOT #'s EXP. DATES 07-12283-00 03/26/2013 07-12284-00 03/27/2013 07-12285-00 03/28/2013 07-12289-00 04/01/2013 07-12290-00 04/02/2013 07-12292-00 04/04/2013 07-12293-00 04/05/2013 07-12296-00 04/08/2013 07-12297-00 04/09/2013 07-12298-00 04/10/2013 07-12300-00 04/12/2013 07-12303-00 04/15/2013 07-12305-00 04/17/2013 07-12306-00 04/18/2013 07-12307-00 04/19/2013 07-12310-00 04/22/2013 07-12312-00 04/24/2013 07-12313-00 04/25/2013 07-12314-00 04/26/2013 07-12317-00 04/29/2013 07-12320-00 05/02/2013 07-12321-00 05/03/2013 07-12324-00 05/06/2013 07-12325-00 05/07/2013 07-12327-00 05/09/2013 07-12331-00 05/13/2013 07-12333-00 05/15/2013 07-12335-00 05/17/2013 07-12338-00 05/20/2013 07-12340-00 05/22/2013 07-12341-00 05/23/2013 07-12345-00 05/27/2013 07-12346-00 05/28/2013 07-12347-00 05/29/2013 07-12349-00 05/31/2013 07-12352-00 06/03/2013 07-12354-00 06/05/2013 07-12355-00 06/06/2013 07-12362-00 06/13/2013 07-12363-00 06/14/2013 07-13002-00 06/19/2013 07-13003-00 06/20/2013 07-13004-00 06/21/2013 07-13007-00 06/24/2013 07-13008-00 06/25/2013 07-13009-00 06/26/2013 07-13010-00 06/27/2013 07-13014-00 07/01/2013 07-13015-00 07/02/2013 07-13017-00 07/04/2013
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the District of Columbia, US Virgin Islands and Puerto Rico, and the states of CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MS, NC, ND, NE, NH, NJ, NM, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, VE, WA, WI, and WV and the coutries of India, Argentina, Australia, Azerbaijan, Belarus, Canada, China, Colombia, Egypt, Germany, Guatemala, Israel, Japan, Malaysia, Mexico, Nepal, Netherlands, Peru, Philippines, Russia Fed., Singapore, South Africa, South korea, Thailand, and Vietnam.
  • Descripción del producto
    epoc BGEM Test Card (Catalogue number CT-1004-00-00). || quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Epocal, 2935 Conroy Rd, Ottawa Canada Ontario
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA