Events

Recall of LIFECODES HLA-C TYPING KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by IMMUCOR GTI DIAGNOSTICS 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
    92713
  • Event Risk Class
    II
  • Event Initiated Date
    2016-04-29
  • 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
    It has been determined that the threshold set for hla-c eres probes 380 382 384 and 385 are set high and may result in false negative probe results. the probes resolve the following cwd alleles probe 380 resolves c*03:06 probe 382 resolves c*12:13 probe 384 resolves c*01:08 and probe 385 resolves c*08:06.

Device

LIFECODES HLA-C TYPING KIT
  • Model / Serial
    Model Catalog: 628921 (Lot serial: Lot # 10235B)
  • Product Description
    Lifecodes HLA-C eRES SSO Typing Kit
  • Manufacturer
    IMMUCOR GTI DIAGNOSTICS INC.

Manufacturer

IMMUCOR GTI DIAGNOSTICS INC.
  • Manufacturer Address
    WAUKESHA
  • Manufacturer Parent Company (2017)
    Hologic, Inc.
  • Source
    HC