Alerta De Seguridad para BD PrepMate™ Syringing Pipette

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por BD 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
  • 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
    Field safety notice: bd prepmate™ syringing pipette medical device manufacturer, bd diagnostics, has issued a field safety notice concerning bd prepmate™ syringing pipette shipped between 31 august 2010 and march 2012. the affected devices can be found in the following products: product name catalog no. bd prepstain™ gyn 480 disposable kit 490542 bd prepstain™ suringing pipettes 240 490517 bd prepstain™ gyn 480 disposable test kit with precoat slides 490523 bd prepstain™ installation kit (precoat) 490528 manual method 1:480 test kit (precoat) 490529 according to bd, the affected devices may leak and decrease the dispensing volume of the sample. the root cause is determined to be a dimensional issue with the barrel of the syringe. age of the device may also be a factor in relation to the leaking. bd observed that a leaking pipette is usually at least 6 months old, while some can be as early as 4 months old. bd recommends the affected users to refer to the operator’s manual and inspect the centrifuge tubes so as to make sure correct amount of sample has been transferred. if a pipette is found to be defective, users are suggested to discard the pipette and contact bd for replacement. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BD PrepMate™ Syringing Pipette
  • Manufacturer