Events

Alerta De Seguridad para BD PrepStain Slide Processors

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

¿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
    2013-08-16
  • Fecha de publicación del evento
    2013-08-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130816a.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: bd prepstain slide processors medical device manufacturer, bd has issued a medical device safety alert concerning the following prepstain slide processors: prepstain ag with catalogue numbers 05cr00021, 05cr00021r, 05cr00022, 05cr00022r, 05cr00023 and 05cr00023r prepstain tecan us-i with catalogue numbers 799-13000-00 and 799-13000-00r prepstain tecan us-ii with catalogue numbers 799-14000-00 (490100) and 799-14000-00r (490407) based on a report from the field, bd has determined that a prepstain slide processor rack setting was incorrectly entered on one prepstain system during a routine preventive maintenance visit by a bd field service representative. this incorrect rack setting has the potential to cause a sample mismatch for specimen test results. to determine whether a device is impacted by a similar error, bd advises users to observe a full 48 slide run (approximately 45 minutes) that will verify the appropriate gyn and non-gyn prepstain system operations during sample transfer. the rack setting inspection procedure is described in the safety notice. if the instrument is not impacted by this issue, no further action will be necessary. if the instrument is impacted, a bd service representative will schedule an on-site visit to adjust the rack settings. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 august 2013.

Device

BD PrepStain Slide Processors
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BD PrepStain Slide Processors
  • Manufacturer
    BD

Manufacturer

BD