Events

Recall of HLA FUSION SOFTWARE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ONE LAMBDA 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
    52642
  • Event Risk Class
    II
  • Event Initiated Date
    2011-01-24
  • 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
    The use of hla fusion version 2.0.0-sp1 rssoh1ac_update.Exe with analysis of following kits/products may cause a conversion error giving incorrect test results.

Device

HLA FUSION SOFTWARE
  • Model / Serial
    Model Catalog: FUSPGR (Lot serial: version 2.0.0 SP1 RSSOH1AC)
  • Product Description
    HLA Fusion Software version 2.0.0-SP1 RSSOH1AC_Update.exe
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC