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 || Importer: ROCHEM BIOCARE COLOMBIA S.A.S.

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
    RRD-090616
  • Event Number
    INVIMA 2013RD-0002654
  • Date
    2016-06-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=134
  • 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
    Low concentrations of reagent contained in vial 3 during batch production. as a result, the concentration of the her2 test is too low, causing reduction of the quality of the coloration, according to the variability of the tissues. when her2 cish pharmdx kit, code sk109 is used in accordance with the instructions for use, blue and red discolorations are easily visible in the normal cells of the tissue sample. if these control signals are not identified in the normal cells, the results of the tests may not be conclusive for the affected flock. the inability to clearly identify such red and blue signals in normal cells indicates a failure of the evaluation and the test should be repeated with a new batch. this may cause a potential delay in diagnosis. however, if the control signals are not checked according to the instructions for use, there is a risk of erroneous diagnosis due to a false negative result.

Device

HER2 CISH pharm dx

Manufacturer

DAKO || Importer: ROCHEM BIOCARE COLOMBIA S.A.S