Events

Alerta De Seguridad para HemosIL PT-Fibrinogen HS PLUS

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

¿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
    2014-12-02
  • Fecha de publicación del evento
    2014-12-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141202a.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: instrumentation laboratory hemosil pt-fibrinogen hs plus the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning hemosil pt-fibrinogen hs plus manufactured by instrumentation laboratory. according to the manufacturer, some vials of hemosil pt-fibrinogen hs plus exhibit a yellow/brownish colour after reconstitution instead of the typical white to off-white colour. these vials were observed to cause prolonged prothrombin (pt) clotting times. this issue is attributed to higher levels of residual moisture in some vials. corrective action has been implemented starting with lot n0640734 (jun2014) to prevent further occurrences of excess moisture in the vials. the manufacturer advises the affected users to: discard vials exhibiting yellow/ brownish colour after reconstitution; and run quality controls at least once every 8 hours in accordance with good laboratory practice and insert sheet instructions. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con477294 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 december 2014.

Device

HemosIL PT-Fibrinogen HS PLUS
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Instrumentation Laboratory HemosIL PT-Fibrinogen HS PLUS
  • Manufacturer
    Instrumentation Laboratory

Manufacturer

Instrumentation Laboratory