Events

Recall of LIAISON SYSTEM - 25 OH VITAMIN D TOTAL

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

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
    65741
  • Event Risk Class
    II
  • 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
    In affected lots recovery in plasma (edta lithium heparin) specimens may exhibit on average a 36% positive bias (with a 95% confidence interval of 26% to 46%). serum specimens are recovering as expected.

Device

LIAISON SYSTEM - 25 OH VITAMIN D TOTAL
  • Model / Serial
    Model Catalog: 310600 (Lot serial: >10 contact manufacturer)
  • Product Description
    LIAISON 25 OH VITAMIN D TOTAL ASSAY
  • Manufacturer
    DIASORIN INC.

Manufacturer

DIASORIN INC.
  • Manufacturer Address
    STILLWATER
  • Manufacturer Parent Company (2017)
    DiaSorin SpA
  • Source
    HC