Alerta De Seguridad para ortho biovue system cassettes

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Ortho Clinical 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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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: ortho clinical diagnosticsortho biovue system cassettes the medicines and healthcare products regulatory agency(mhra), united kingdom posted a field safety notice concerningortho biovue system cassettes, manufactured by ortho clinical diagnostics. ortho clinical diagnostics has identified isolated occurrences of improperly positioned cassette labels for certain products.An investigation confirmed that the cause of the issue occurred on one of our three manufacturing lines following a particular sequence of events.The occurrence rate of the issue is very low. the use of an affected multi-reagent cassette may lead to false negative or false positive results causing a potential misclassification of the patient or donor blood groups or incorrect antibody detection results. there is no risk associated with the use of an affected single-reagent cassette since all wells contain the same reagent. the manufacturer advises users to inspect all cassettes from the potentially affected lots remaining in facility prior to use, by referring to the ortho biovue system cassette inspection procedure for visual detailed instructions; and do not use cassettes with an incorrectly positioned label and discard the affected cassette in accordance with local regulations. according to the local supplier, the affected products were distributed in hong kong. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con287036 if you are in possession of the product, please contact your supplier for necessary actions. posted on 9 july 2013.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ortho Clinical DiagnosticsORTHO BioVue System Cassettes
  • Manufacturer