Events

Alerte De Sécurité sur NADAL hCG Pregnancy rapid test

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par nal von minden GmbH.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2017-01-04
  • Date de publication de l'événement
    2017-01-04
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170104.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: nal von minden nadal hcg pregnancy rapid test the medicines and healthcare products regulatory agency (mhra) of the united kingdom has posted a medical device safety alert concerning nadal hcg pregnancy rapid test [item number: 142002; lot numbers: all], manufactured by nal von minden gmbh. this safety notice concerns the limitations of the nadal hcg pregnancy rapid test, which is calibrated for intact hcg and detects intact hcg only. the proportions of intact hcg and other hcg forms in serum and urine may differ according to the stage of pregnancy in which it is analysed. according to the manufacturer, in rare cases, at a more advanced stage of pregnancy (approximately week 5-8 of pregnancy), increased amounts of hcg-beta-core fragments may be present in the urine hindering the detection reaction and leading to false negative results in spite of high hcg concentration. customers are advised to pay attention to this further limitation when evaluating the test result. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-19-december-23-december-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 january 2017.

Device

NADAL hCG Pregnancy rapid test
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Nal von minden NADAL hCG Pregnancy rapid test
  • Manufacturer
    nal von minden GmbH

Manufacturer

nal von minden GmbH