Events

Alerta De Seguridad para AutoMate 2500 Family

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Beckman Coulter.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2017-06-07
  • Fecha de publicación del evento
    2017-06-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170607b.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Beckman Coulter AutoMate 2500 Family
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter