Events

Alerte De Sécurité sur AutoMate 2500 Family

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

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
    2017-06-07
  • Date de publication de l'événement
    2017-06-07
  • 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_20170607b.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: beckman coulter automate 2500 family medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its automate 2500 family. the manufacturer has identified there is a potential that a component on the recapper module did not have the required coating specified for that part. the coating on the recapper component helps to both ensure the longevity of the part, and help the gripper to release the parafilm so it properly seals to the tube. if there is an uncoated component on customer’s recapper, this could lead to tubes not being properly sealed. the manufacturer has determined that this situation would be highly unlikely to occur and the test results are not affected. the manufacturer will schedule a time to affected customer’s sites and confirm whether the proper coating on the recapper component is present, and replace the component if necessary. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 june 2017.

Device

AutoMate 2500 Family
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter AutoMate 2500 Family
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter