Events

Recall of LIFECODES HLA-DQA1/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
    97294
  • Event Risk Class
    III
  • Event Initiated Date
    2015-12-21
  • 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
    Immucor transplant diagnostics inc. is investigating a single instance of false positive reactivity of probe dqb253 associated with an allele pair of dqb1*03:03:02:01 dqb1*03:04:01. a false positive result causes the exclusion of dqb1*03:03:02:01/ 03:04:01 as a possible allele combination. the false positive reactivity is only observed in a dqb1*03:03:02:01 dqb1*03:04:01 heterozygous combination. other combinations with dqb1*03:03:02:01 or dqb1*03:04:01 are not affected.

Device

LIFECODES HLA-DQA1/B1 SSO TYPING KIT
  • Model / Serial
    Model Catalog: 628930 (Lot serial: 07065B); Model Catalog: 628930 (Lot serial: 11184C)
  • Product Description
    LIFECODES HLA-DQA1/B1 Typing Kit
  • Manufacturer
    IMMUCOR GTI DIAGNOSTICS INC.

Manufacturer

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