Events

Alerta De Seguridad para UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems

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
    2016-05-09
  • Fecha de publicación del evento
    2016-05-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160509.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 unicel dxh 800 and unicel dxh 600 coulter cellular analysis systems medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its unicel dxh 800 and unicel dxh 600 coulter cellular analysis systems. the affected products are identified as follows: unicel dxh 800 coulter cellular analysis system reference.: 629029, b24465, b24802, b68304 software version: 2.0.0.0 and greater unicel dxh 600 coulter cellular analysis system reference: b23858 software version: 1.0.0.0 and greater the manufacturer has identified an issue where the rbc aperture baths can contain residue in the sweep flow fittings. this residue may potentially create increased background failures, flagged results and vote outs for rbc and plt parameters. affected users are instructed to: address any daily checks system alarms and background failures as indicated in the online help or instructions for use (part number b26647ac and b16421ad); and monitor flags on patient and control results according to their laboratory protocols. according to the local supplier, unicel dxh 800 coulter cellular analysis system is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 may 2016.

Device

UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Beckman Coulter UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter