Events

Alerta De Seguridad para Unicel DxH 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
    2015-12-07
  • Fecha de publicación del evento
    2015-12-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151207b.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 cellular analysis systems medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning unicel dxh 800, dxh slidemaker stainer (sms) and dxh 600 cellular analysis systems. the affected products are identified as follows: dxh 800: reference number: 629029, b24465, b24802; software version: 3.0.2.0 dxh sms: reference number: 775222; software version: 3.0.2.0 dxh 600: reference number: b23858; software version: 1.1.1.0 the manufacturer has determined that the software for the affected dxh systems allows the creation of multiple orders with the same specimen identification (id) but different patient identification when manually editing pending orders at the system manager. the issue does not occur for edits of released results or for test orders requested through host transmission. according to the manufacturer, the issue creates the potential for sample misidentification and possibility of releasing erroneous results. the manufacturer is advising customers not to edit the specimen id for a pending test order at the system manager’s worklist – pending or worklist – review tabs. 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 december 2015.

Device

Unicel DxH Cellular Analysis Systems
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Beckman Coulter Unicel DxH Cellular Analysis Systems
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter