Events

Safety Alert for HER2 CISH PHARM DX

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by DAKO NORTH AMERICA INC.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R-RD-04-12-13.
  • Event Number
    2013RD-0002654
  • Date
    2013-12-26
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=213
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    If the recommended quality control procedure is not followed, there may be a risk in the counting of the red signals, which could be incorrect the her2 / cen-17 relationship and generate potentially negative negative results.

Device

HER2 CISH PHARM DX
  • Model / Serial
  • Product Description
    Determination of the analyte related to samples from the human body.
  • Manufacturer
    DAKO NORTH AMERICA INC

Manufacturer

DAKO NORTH AMERICA INC