Events

Field Safety Notices about Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2

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
    2017-12-12
  • Event Date Posted
    2017-12-29
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2017/12/29/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-monoclonal-mouse-anti-human-cdx2-clone-dak-cdx2-histologija-citoloski-reagens/
  • 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 certificate of analysis ("coa") and the inner pack of "monoclonal mouse anti-human cdx2, clone dak-cdx2" (m3636) contain an error in the protein concentration value of 292.7 mg / l, which is sixteen times greater than the correct concentration. which is 18.3 mg / l. the "monoclonal mouse anti-human cdx2, clone dak-cdx2" (m3636) medical device will perform its function according to the manufacturer's intention, that is, this error does not affect the quality, performance or effectiveness of the medical device. therefore, there is no change in the concentration itself, and the outer packaging indicates the correct concentration of 18.3 mg / l. if the product is diluted with an inaccurate concentration greater than 292.7 mg / l, a diminished color strength will be seen, resulting in poor or negative coloration. this should be easy to detect both in internal positive normal tissue and in recommended positive external process controls. to date, the manufacturer has received only one complaint from the user, who noticed this during testing, and no adverse effects have been reported on any patient.

Device

Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2

Manufacturer

Dako Denmark