Device Recall epoc BGEM Test Card

  • Model / 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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Epocal, 2935 Conroy Rd, Ottawa Canada Ontario
  • Manufacturer Parent Company (2017)
  • Source
    USFDA