Events

Recall of DAKO HERCEP TEST KIT

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
    75942
  • Event Risk Class
    III
  • Event Initiated Date
    2005-11-07
  • 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
    Formulation error in visualization reagent (vial 3). concentration of polyethylene glycol was 0.3% not 3.0%. error may result in reduction in staining intensity for assessment of her2 gene over expression.

Device

DAKO HERCEP TEST KIT
  • Model / Serial
    Model Catalog: K5209 (Lot serial: 00016943); Model Catalog: K5207 (Lot serial: 00016943); Model Catalog: K5204 (Lot serial: 00016965); Model Catalog: K5205 (Lot serial: 00016965); Model Catalog: K5207 (Lot serial: 00016965); Model Catalog: K5209 (Lot serial: 00016965); Model Catalog: K5204 (Lot serial: 00018107); Model Catalog: K5205 (Lot serial: 00018107); Model Catalog: K5205 (Lot serial: 00016943); Model Catalog: K5204 (Lot serial: 00016943); Model Catalog: K5209 (Lot serial: 00018107); Model Catalog: K5207 (Lot serial: 00018107)
  • Product Description
    HercepTest Visualization Reagent
  • Manufacturer
    DAKO NORTH AMERICA INC.

Manufacturer

DAKO NORTH AMERICA INC.