Events

Field Safety Notices about HER2 CISH pharmDx Kit

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Dako Denmark.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2014-02-01
  • Event Date Posted
    2014-10-02
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2014/02/10/%D0%BE%D0%B1%D0%B0%D0%B2%D0%B5%D1%88%D1%82%D0%B5%D1%9A%D0%B5-%D0%BE-%D0%BC%D0%B5%D1%80%D0%B8-%D0%BF%D0%BE%D0%B2%D0%BB%D0%B0%D1%87%D0%B5%D1%9A%D0%B0-%D1%81%D0%B0-%D1%82%D1%80%D0%B6%D0%B8%D1%88%D1%82/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    The manufacturer has reported that when lot 00092789 and lot 20002057 of said medical device are used, weak and non-homogenized red signals are obtained. reduced activity of one batch of enzyme-antibody conjugates has been identified as a major cause of weak red signals. if the user follows the procedures recommended in the section "quality control" of the instructions for use of the medical device, this signal will eliminate, and the result obtained will not be considered, and if the recommended procedures in the section "quality control" are not followed, this result will be interpreted as weak or false negative.

Device

HER2 CISH pharmDx Kit
  • Model / Serial
    00092789, 20002057
  • Manufacturer
    Dako Denmark

Manufacturer

Dako Denmark