Events

Alerta De Seguridad para VerifyNow IIb/IIIa 25-Test and 10-Test Kits

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

¿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
    2014-03-04
  • Fecha de publicación del evento
    2014-03-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140304.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: accumetrics verifynow iib/iiia 25-test and 10-test kits the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning verifynow iib/iiia 25-test and 10-test kits [product codes: 85011 and 85310; reference number: ivd14.014; capa 13-014] manufactured by accumetrics. during its surveillance, the manufacturer has determined that the affected verifynow iib/iiia test kit lots may result in the reporting of an erroneous low platelet aggregation unit (pau) result. corrective actions are being implemented to prevent these issues from affecting future lots of verifynow iib/iiia test kits. the manufacturer has not received any reports of adverse events for these issues. according to the manufacturer, a lower than actual or expected pau values may contribute to excess administration of iib/iiia anti-platelet agents, which has the potential to lead to an adverse event. typically, higher doses of anti-platelet agents are associated with higher risk of bleeding. the manufacturer advises all affected users to check their inventory to determine if they have any affected verifynow iib/iiia test kits. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con382708 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 march 2014.

Device

VerifyNow IIb/IIIa 25-Test and 10-Test Kits
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Accumetrics VerifyNow IIb/IIIa 25-Test and 10-Test Kits
  • Manufacturer
    Accumetrics

Manufacturer

Accumetrics