Events

Recall of 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
    110800
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-27
  • 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 certificate of analysis (coa) and the primary labels of the affected vials of m3636 were mislabeled with an incorrect protein concentration value of 292.7 mg/l which is sixteen times higher than the correct concentration of 18.3 mg/l.

Device

MONOCLONAL MOUSE ANTI-HUMAN CDX2
  • Model / Serial
    Model Catalog: M3636 (Lot serial: M363629-2 lot 10117138); Model Catalog: M3636 (Lot serial: M363601-2 lot 10121392); Model Catalog: M3636 (Lot serial: M363629-2 lot 10121395); Model Catalog: M3636 (Lot serial: M363601-2 lot 10117361)
  • Product Description
    MONOCLONAL MOUSE ANTI-HUMAN CDX2;MONOCLONAL MOUSE ANTI-HUMAN CDX2 CLONE DAK-CDX2
  • Manufacturer
    DAKO NORTH AMERICA INC.

Manufacturer

DAKO NORTH AMERICA INC.