Events

Recall of LIFECODES HLA-DPA1/B1 SSO 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
    91914
  • Event Risk Class
    III
  • Event Initiated Date
    2018-03-09
  • 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
    As a result of a complaint investigation immucor found that a number of its lifecodes hla sso typing kits were affected by an error in the match it! dna 3.27.0 allele database update. the lot specific software files for these kits had incorrect probe assignments for some alleles which could have led to a potential mistype of certain alleles.

Device

LIFECODES HLA-DPA1/B1 SSO TYPING KIT
  • Model / Serial
    Model Catalog: 628936 (Lot serial: 12085A); Model Catalog: 628936 (Lot serial: 3004756); Model Catalog: 628930 (Lot serial: 3004970); Model Catalog: 628930 (Lot serial: 06306A); Model Catalog: 628930 (Lot serial: 10205A); Model Catalog: 628923 (Lot serial: 11125A); Model Catalog: 628923 (Lot serial: 04226A)
  • Product Description
    LIFECODES HLA-DPA1/B1 SSO TYPING KIT;LIFECODES HLA-DQA1/B1 SSO TYPING KIT;LIFECODES HLA-DRB1 SSO TYPING KIT
  • Manufacturer
    IMMUCOR GTI DIAGNOSTICS INC.

Manufacturer

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