Events

Safety Alert for Liaison Biotrin Parvovirus B19 IgM

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by DiaSorin S.p.A..

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
  • Date
    2012-12-12
  • Event Date Posted
    2012-12-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121212b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: diasorin liaison biotrin parvovirus b19 igm medical device manufacturer, diasorin s.P.A. has issued a field safety notice concerning liaison biotrin parvovirus b19 igm (catalogue number 317010 and lot number: 129014x, 129014x/1, 129015x and 129015x/1). through internal testing, diasorin has become aware that the kit lots identified above have a potential to produce an increased rate of positive results. the manufacturer recommends the affected users to retest all initially reactive specimens unless, as part of the laboratory policy, these samples have already been confirmed by other method or by clinical evidence. the manufacturer is offering parvovirus b19 igm eia, code v619im free of charge to perform the retesting. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 12 december 2012.

Device

Liaison Biotrin Parvovirus B19 IgM
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: DiaSorin Liaison Biotrin Parvovirus B19 IgM
  • Manufacturer
    DiaSorin S.p.A.

Manufacturer

DiaSorin S.p.A.