Events

Recall of BIOTRIN CONTROL PARVOVIRUS B19 IGM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DIASORIN IRELAND LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    27736
  • Event Risk Class
    III
  • Event Initiated Date
    2014-01-17
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Internal investigation confirmed that c of a of biotrin controlparvovirus b19 igm is reporting an incorrect negative control range for the liaison xl application when used in combination with biotrin parvovirus b19 igm kit.

Device

BIOTRIN CONTROL PARVOVIRUS B19 IGM
  • Model / Serial
    Model Catalog: 317081 (Lot serial: 158008X)
  • Product Description
    BIOTRIN CONTROL PARVOVIRUS B19 IGM
  • Manufacturer
    DIASORIN IRELAND LTD.

Manufacturer

DIASORIN IRELAND LTD.
  • Manufacturer Address
    BLACKROCK
  • Manufacturer Parent Company (2017)
    DiaSorin SpA
  • Source
    HC