Events

Recall of FLEX MONOCLONAL MOUSE ANTI-HUMAN CDX2

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DAKO NORTH AMERICA 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
    42752
  • Event Risk Class
    III
  • Event Initiated Date
    2016-09-09
  • 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
    Reason for recall: a packaging error resulted so the ifu for dako product ir 062 (flex monoclonal mouse anti - human cd15) was found in the product instead of the ifu for flex monoclonal mouse anti-human cdx2.

Device

FLEX MONOCLONAL MOUSE ANTI-HUMAN CDX2
  • Model / Serial
    Model Catalog: IR80 (Lot serial: 10112879)
  • Product Description
    FLEX MONOCLONAL MOUSE ANTI-HUMAN CDX2
  • Manufacturer
    DAKO NORTH AMERICA INC.

Manufacturer

DAKO NORTH AMERICA INC.