Events

Safety Alert for Pregnancy Testing - Pencils (HCG Midstream test)

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by MP Manufacturer Unknown Sender: Alfa Scientific Designs, Inc., USA.

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
    2016-02-12
  • 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
    The in vitro diagnostic medical device is not affixed with the ce conformity marking and the notified body no. (does not meet the requirements of mn 102: 2001 64, item 65), there is no data on the manufacturer and the manufacturer's authorized representative in the european economic area (does not meet the requirements of mn 102: 2001 annex 1, clause 13.4.1), no instructions for use (not in accordance with mn 102: 2001 annex 1 13.4.9). the packaging of the appliance, nor the instructions for use, does not bear the ce conformity marking and the number of the notified body (does not comply with the requirements of mn 102: 2001 64, 65), there is no data on the manufacturer's authorized representative in the european economic area (not in compliance with mn 102: 2001 annex 1 clause 13.4.1) requirements).
  • Action
    Disallowed to market

Device

Pregnancy Testing - Pencils (HCG Midstream test)

Manufacturer

MP Manufacturer Unknown Sender: Alfa Scientific Designs, Inc., USA
  • Manufacturers representative
    UAB Medicinos Marketingas
  • Source
    MH