Events

Recall of MATCHIT! PLATELET ANTIBODY

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
    23484
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-29
  • 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
    The paklx instructions for use (ifu) version 303285.Ifuen rev k and the matchit! platelet antibody software database were not aligned. the ifu states that a minimum of 60 events must be collected per bead region. the matchit! platelet antibody software database requires a minimum of 100 events per bead region. this discrepancy caused invalid results when using the matchit! platelet antibody software to analyze a bead.

Device

MATCHIT! PLATELET ANTIBODY
  • Model / Serial
    Model Catalog: PLX (Lot serial: 3005538); Model Catalog: 303285 (Lot serial: 3005391); Model Catalog: PLX (Lot serial: 3005391); Model Catalog: 303285 (Lot serial: 3004895); Model Catalog: 888622 (Lot serial: 3004895); Model Catalog: PLX (Lot serial: 3004895); Model Catalog: 888622 (Lot serial: 3005538); Model Catalog: 303285 (Lot serial: 3005538); Model Catalog: 888622 (Lot serial: 3005391)
  • Product Description
    PAKLX - MATCHIT! PLATELET ANTIBODY SOFTWARE (V1.1)
  • Manufacturer
    IMMUCOR GTI DIAGNOSTICS INC.

Manufacturer

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