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
    137448
  • Event Risk Class
    II
  • Event Initiated Date
    2013-08-09
  • 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
    Hla fusion software version 2.0.0 sp4.1 using luminex xponent run files may generate a mis-assignment when using product(s) labtype sso dna typing tests - drb1(cat id rssoh2b1) lots 07b and 008. the hla fusion software version 2.0.0 sp4.1 may cause a conversion error on certain probes in the rssoh2b1 kits giving incorrect test results.

Device

HLA FUSION SOFTWARE
  • Model / Serial
    Model Catalog: FUSPGR (Lot serial: Version 2.0.0 SP4.1)
  • Product Description
    HLA Fusion Software (Version 2.0.0 SP4.1)
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC