Events

Alerte De Sécurité sur ACL TOP Family Coagulation Systems

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

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
    2013-07-25
  • Date de publication de l'événement
    2013-07-25
  • 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_20130725a.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: werfen acl top family coagulation systems it has come to our attention that the medical device manufacturer, werfen group, instrumentation laboratory has initiated a medical device field safety corrective action concerning acl top family coagulation systems. the affected models are acl top, acl top cts, acl top 700, acl top 700 cts, acl top 700 las, acl top 500 cts and acl top 300 cts. it has come to our attention that the medical device manufacturer, werfen group, instrumentation laboratory has initiated a medical device field safety corrective action concerning acl top family coagulation systems. the affected models are acl top, acl top cts, acl top 700, acl top 700 cts, acl top 700 las, acl top 500 cts and acl top 300 cts. the extent of the shortened clotting times varies from instrument to instrument and is not reproducible on all instruments. in certain instances, this issue has manifested itself as a downward shift in aptt clotting times of greater than 10 seconds. the manufacturer is working on a software mitigation to address this issue. until available, the manufacturer advises users use the workaround described in the field safety notice. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 july 2013.

Device

ACL TOP Family Coagulation Systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Werfen ACL TOP Family Coagulation Systems
  • Manufacturer
    Werfen Group

Manufacturer

Werfen Group