Device Recall Epi proColon Plasma Quick Kit

  • Model / Serial
    Lot Number: 16903908; Expiration Date: 28 Feb 2018
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Shipped to one U.S. distributor in NY. Further distributed in 9 states: CA, MI, NC, NE, NJ, PA, TN, TX, UT.
  • Product Description
    Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Epigenomics Ag, Geneststr. 5, Berlin Germany
  • Manufacturer Parent Company (2017)
  • Source
    USFDA