Events

Recall of Device Recall Epi proColon Plasma Quick Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Epigenomics Ag.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79364
  • Event Risk Class
    Class 2
  • Event Number
    Z-1077-2018
  • Event Initiated Date
    2017-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162134
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, colorectal neoplasia, DNA methylation and hemoglobin detection - Product Code PHP
  • Reason
    The diagnostic test kit may produce invalid test runs which may delay test results.
  • Action
    Users were instructed to discontinue use of the kits, complete the acknowledgement form, and distribute the notification to relevant persons within organization. If kits were further distributed the consignee was asked to forward the safety notice to these entities.

Device

Device Recall Epi proColon Plasma Quick Kit
  • Model / Serial
    Lot Number: 16903908; Expiration Date: 28 Feb 2018
  • Product Classification
    Hematology and Pathology Devices
  • 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
    Epigenomics Ag

Manufacturer

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