Events

Avis De Sécurité sur Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par Dako Denmark.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2017-12-12
  • Date de publication de l'événement
    2017-12-29
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    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 / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    10121392
  • Manufacturer
    Dako Denmark

Manufacturer

Dako Denmark