Events

Safety Alert for Plates for IVD Research - Prime Test Panel G

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
    1
  • Date
    2018-05-18
  • 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
    The name and address of the manufacturer of the medical device is not specified and the name and address of the manufacturer's authorized representative in the european economic area are not specified (not in compliance with the requirements of annex 1, paragraph 13.4.1 of the ivd regulation); the label provided on the medical device packaging indicates that the objective glass is coated with food or chemical substances, as well as the "see". instructions for use ', but not specified in the instructions for use, the instructions for use have not been included (not in compliance with the requirements of annex 1, points 13.4.2 and 13.1 of the ivd regulation).
  • Action
    Do not allow to enter the Lithuanian market

Device

Plates for IVD Research - Prime Test Panel G

Manufacturer

Not specified
  • Manufacturers representative
    UAB Urmo Group
  • Source
    MH