Events

Safety Alert for Diagnostic reagents for drug detection Dip Card Panel

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Not specified.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event Number
    3
  • Date
    2018-12-05
  • Event Country
    Lithuania
  • Event Source
    MH
  • Event Source URL
    http://www.vaspvt.gov.lt/node/115
  • Notes / Alerts
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lithuania.
  • Extra notes in the data
  • Reason
    Ivd medical devices, their packaging and instructions for use do not bear the ce marking, which does not meet the requirements of point 61 of the ivd regulation; the name and address of the authorized representative of the manufacturer of the ivd medical device in the european economic area is not specified, which does not meet the requirements of annex 1, paragraph 13.4.1 of the ivd regulation.
  • Action
    Do not allow to enter the Lithuanian market

Device

Diagnostic reagents for drug detection Dip Card Panel

Manufacturer

Not specified
  • Manufacturers representative
    UAB Urmo Group
  • Source
    MH