Events

Recall of MATCH IT TM DNA SOFTWARE V 1.2

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
    44984
  • Event Risk Class
    II
  • Event Initiated Date
    2018-02-11
  • 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 when using match it! dna software v1.2.3 (with the pairwise functionality turned off) on a win 7 32-bit computer to analyze hla-a typing the software does not correctly load the suggested assignment table when navigating between samples that contain complex numbers of hla-a allele-string pairs. when the user navigates from one sample to the next the software does not automatically assign a typing into the assigned view field when the auto assign feature is activated in preferences. if the user attempts to make a manual assignment to the assigned view field the software will crash. it has also been determined that there is a possibility of a mistype when using match it! dna software v1.2.4 (with the pairwise functionality turned off) on a win 7 32-bit computer to analyze hla-a typing. if the user navigates from one sample to the next sample the software can maintain the previous sample typing in the assigned view field in addition to the suggested assignments. if the user attempts to make a manual assignment the software will freeze. there is no warning that the typing in assigned view is incorrect.

Device

MATCH IT TM DNA SOFTWARE V 1.2
  • Model / Serial
    Model Catalog: 888623 (Lot serial: NA)
  • Product Description
    MATCH IT! DNA SOFTWARE
  • Manufacturer
    IMMUCOR GTI DIAGNOSTICS INC.

Manufacturer

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