Events

Recall of WB CORQC

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by IMMUCOR 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
    154828
  • Event Risk Class
    III
  • Event Initiated Date
    2013-02-13
  • 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 has had complaints of hemolysis in wb corqc tube 1 of this kit lot. the investigation has demonstrated microbial contamination in one example of wb corqc tube 1. wb corqc tube 1 lot 232192 is a component of wb corqc kit lot 236154 and 236154a. the product expired on 2013-02-07.

Device

WB CORQC
  • Model / Serial
    Model Catalog: 0066090 (Lot serial: Kit Lot # 236154A)
  • Product Description
    Immucor WB corQC
  • Manufacturer
    IMMUCOR INC.

Manufacturer

IMMUCOR INC.
  • Manufacturer Address
    NORCROSS
  • Manufacturer Parent Company (2017)
    Ivd Holdings Inc
  • Source
    HC