Events

Alerta De Seguridad para Captia™ Varicella-Zoster Virus IgG Kit

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

¿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
    2012-06-11
  • Fecha de publicación del evento
    2012-06-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120611.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: trinity biotech captia™ varicella-zoster virus igg kit medical device manufacturer, trinity biotech, has issued a field safety notice concerning captia™ varicella-zoster virus igg kit. the affected kit lot numbers are 2325600-566, 2325600-567, 2325601-566 and 2325601-567. the manufacturer noted that a drop in absorbance value of the calibrator may occur. this could result in an invalid test run, with the calibrator running low causing the positive control to run high out of its assigned isr range. if the test resulted in a valid run, such as all kit controls and calibrator met quality control criteria as stated in the package insert, the patient results can be reported and a re-evaluation of patient results was not necessary. according to the local supplier, tin hang technology limited, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 11 june 2012.

Device

Captia™ Varicella-Zoster Virus IgG Kit
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Trinity Biotech Captia™ Varicella-Zoster Virus IgG Kit
  • Manufacturer
    Trinity Biotech

Manufacturer

Trinity Biotech