Events

Alerta De Seguridad para PROTIME InRhythm System PT Test Cuvettes

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

¿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
    2016-02-11
  • Fecha de publicación del evento
    2016-02-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160212b.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: protime inrhythm system pt test cuvettes medicines & healthcare products regulatory agency (mhra) has issued a medical device safety alert concerning protime inrhythm system pt test cuvettes [lot number: k5ptd402-p1, k5ptd403-p2, k5ptd404-p3, k5ptd405-p4], manufactured by accriva diagnostics. during its surveillance testing programme, the manufacturer has determined that the above four lots of the inrhythm pt test cuvettes are exhibiting accelerated degradation during both refrigerated and room-temperature storage conditions. this degradation indicates the product will not meet claimed performance for its full labelled shelf-life and in the case of room-temperature storage may lead to erroneous results or qc test failures. according to the manufacturer, no adverse events have been reported due to this issue. product recall is ongoing. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 february 2016.

Device

PROTIME InRhythm System PT Test Cuvettes
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: PROTIME InRhythm System PT Test Cuvettes
  • Manufacturer
    Accriva Diagnostics

Manufacturer

Accriva Diagnostics