Events

Safety Alert for Pregnancy Tests - Ribbon (HCG Urine DipStrip)

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
    1
  • 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
    In vitro diagnostic medical device unmarked with ce conformity marking (not in compliance with mn 102: 2001 64, item 65), no data on manufacturer and manufacturer's authorized representative in the european economic area (not in compliance with mn 102: 2001 annex 1 clause 13.4.1) , there is no inscription on the use of the device in vitro (does not meet the requirements of mn 102: 2001, annex 1, clause 13.4.7), there is no data on special storage conditions (does not meet the requirements of mn 102: 2001 annex 1, clause 13.4.7), no instructions for use (does not meet mn 102: 2001 annex 13, section 13.4.9).
  • Action
    Disallowed to market

Device

Pregnancy Tests - Ribbon (HCG Urine DipStrip)

Manufacturer

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