Events

Recall of MONOCLONAL RABBIT ANTI-HUMAN POSTMEIOTIC SEGREGATION INCREASED 2 CLONE EP51

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DAKO DENMARK A/S.

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
    33984
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-27
  • 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
    On may 20 2015 it was discovered by dako that the expiration date on the secondary (vial box) label of one lot of product m3647 was erroneously printed as "2106-05" rather than "2016-05".

Device

MONOCLONAL RABBIT ANTI-HUMAN POSTMEIOTIC SEGREGATION INCREASED 2 CLONE EP51
  • Model / Serial
    Model Catalog: M3647 (Lot serial: 10100352)
  • Product Description
    MONOCLONAL RABBIT ANTIHUMAN POSTMEIOTIC SEGREGATION INCREASED 2 CLONE EP51
  • Manufacturer
    DAKO DENMARK A/S

Manufacturer

DAKO DENMARK A/S