Events

Safety Alert for IVD diagnostic test kits (Allergen (egg white) rapid test device, Milk Allergy test device, Shrim (F24) Allergy Rapid test device, Dust Mite test device, Allergen (Cat dander) Rapid test device, Dog Dander Allergy test device, Oak white Allergy test device, Mugwort Allergy test device, Allergen (Ragweed) Rapid test device, Syphilis Rapid test device)

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Assuro Tech. (Hangzhou) Ltd., China.

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
    2
  • Date
    2018-06-12
  • 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
    All instructions for use attached to the ivd tests do not bear the ce conformity marking - do not meet the requirements of point 61 of the ivd regulation; name and address of the manufacturer's authorized representative in the european economic area not specified in the package leaflet accompanying the ivd tests peanut allergy test device, dust mite test device, outer packaging and individual test packaging - not in accordance with annex 1, 13.4.1 of the ivd regulation requirements; lancets in ivd diagnostic test kits for finger puncture and blood sampling for ivd testing, without ce marking, no manufacturer and address, no manufacturer's authorized representative in the european economic area, no batch / serial number, non-sterile medical device (unpacked) it is not possible to separate the lancet according to the lancet structure in a separate package to ensure sterility, lancet has not been used), no information has been added that it should be sterilized before use of the lancet and no indication is given that the measure is intended for single use. can be safely used - does not meet the requirements of mp 39 and annex 1, paragraph 9, 14.3.1, 14.3.3, 14.3.4, 14.3.5, 14.3.614.3.10.
  • Action
    Do not allow to enter the Lithuanian market

Device

IVD diagnostic test kits (Allergen (egg white) rapid test device, Milk Allergy test device, Shrim...

Manufacturer

Assuro Tech. (Hangzhou) Ltd., China
  • Manufacturers representative
    UAB East Scandinavia Company
  • Source
    MH