Events

Alerta De Seguridad para BD ProbeTec Chlamydia trachomatis (CT) Qx Assay and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay

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
    2014-11-14
  • Fecha de publicación del evento
    2014-11-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141114a.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 probetec chlamydia trachomatis (ct) qx assay and the bd probetec neisseria gonorrhoeae (gc) qx assay medical device manufacturer, bd, has issued a field correction action concerning the bd probetec chlamydia trachomatis (ct) qx assay with catalogue number 442959 and the bd probetec neisseria gonorrhoeae (gc) qx assay with catalogue number 442842. the manufacturer has learned that some customers performing the bd probetec chlamydia trachomatis (ct) qx assay and the bd probetec neisseria gonorrhoeae (gc) qx assay with the viper lt instrument are experiencing a higher than expected rate of positive test results (i.E., increased prevalence). this observation is limited to a subset of test results obtained from specimens yielding “max rfu” values in the approximate range of 125 to 250. this includes occasionally obtaining positive results for the assay negative control. based on internal investigations to date, the manufacturer has confirmed that this change in test performance is attributable to an increase in false positive results. the anomaly only impacts ct/gc assay results on the viper lt. the manufacturer will provide affected users with alternative testing methods until the issue of false positive results is addressed. the manufacturer’s representatives will contact users directly to determine which methods/options would be the most viable to satisfy their testing needs. the interim solutions include testing on an alternate platform (viper xtr, probetec, or a competitor’s instrument) or sending the ct/gc testing out to alternate laboratories. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 november 2014.

Device

BD ProbeTec Chlamydia trachomatis (CT) Qx Assay and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx...
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BD ProbeTec Chlamydia trachomatis (CT) Qx Assay and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay
  • Manufacturer
    BD

Manufacturer

BD