Events

Recall of PF4 IGG

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
    39555
  • Event Risk Class
    III
  • Event Initiated Date
    2014-12-18
  • 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
    An error was noted in the manufacture of the pf4 concentrated wash (1ox) which is contained in the lifecodes pf4 enhanced and lifecodes pf4 igg kits manufactured by lmmucor gti diagnostics.

Device

PF4 IGG
  • Model / Serial
    Model Catalog: HAT13G (Lot serial: >10 contact mfg.); Model Catalog: HAT45G (Lot serial: >10 contact mfg.); Model Catalog: 403624 (Lot serial: >10 contact mfg.)
  • Product Description
    Lifecodes PF4 IgG
  • Manufacturer
    IMMUCOR GTI DIAGNOSTICS INC.

Manufacturer

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