Events

Alerta De Seguridad para Oral Fluid Drug Screen Device Saliva Collector

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por SureScreen 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
    2013-07-17
  • Fecha de publicación del evento
    2013-07-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130717a.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: surescreen diagnostics oral fluid drug screen device saliva collector the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) issued a medical device alert concerning oral fluid drug screen device saliva collector manufactured by surescreen diagnostics. the affected models are: orat6v1 oral screen (opi/amp/mamp/coc/thc/mtd) orat2 oral screen (opi/coc) orat6v2 oral screen twist device (opi/amp/mamp/coc/thc/pcp) orat4 oral screen (coc/amp/thc/opi) orat6v3 oral screen twist device (coc/met/bzo/thc/opi/amp) orat6v4 oral screen twist (coc/thc/mamp/mtd/opi/amp) orat3v2 oral screen twist (coc/met/thc) orat6v5 oral screen twist (coc/mamp/opi/amp/mtd/bzo) the manufacturer is issuing a field safety notice for the saliva collector that is an accessory in the oral fluid drug screen device. in certain lots, the sponge may become dislodged from the saliva collector handle prior to or during the oral fluid sample collection process. if the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a choking risk. the manufacturer’s investigation indicates that the sponge may become dislodged on approximately 5% of the saliva collectors from affected lots. the manufacturer advises users to implement the saliva collector inspection process: before using the affected saliva collectors, gently pull the sponge while it is in the wrapper to ensure it remains firmly attached to the handle. immediately discard any saliva collectors if the sponge detaches from the handle. alternatively, contact the manufacturer for replacement product. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con287037 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 july 2013.

Device

Oral Fluid Drug Screen Device Saliva Collector
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: SureScreen Diagnostics Oral Fluid Drug Screen Device Saliva Collector
  • Manufacturer
    SureScreen Diagnostics

Manufacturer

SureScreen Diagnostics