Events

Alerta De Seguridad para vitros immunodiagnostic products nt-probnp calibrators, vitros immunodiagnostic products nt-probnp reagent packs

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
    2014-04-08
  • Fecha de publicación del evento
    2014-04-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140408.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: ortho clinical diagnostics vitros immunodiagnostic products nt-probnp calibrators, vitros immunodiagnostic products nt-probnp reagent packs medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its viitros immunodiagnostic products nt-probnp calibrators (product code 6802157; lot 1110) and vitros immunodiagnostic products nt-probnp reagent packs (product code 6802156; lot 1110). during routine internal testing, the manufacturer identified potential for non-reproducible, higher than expected results that may exceed the decision thresholds for congestive heart failure (chf) when using vitros nt-probnp reagent packs, lot 1110. when using the affected lots of products, elevated results were observed across the measuring range of the assay (5.00 to 35,000 pg/ml and 0.590 to 4130 pmol/l). analysis determined that this issue may affect approximately 1 in 73 test results, or 1.37%. the manufacturer advises affected users to take the following actions:- immediately discontinue using and discard all remaining vitros nt-probnp calibrators and reagent packs, lot 1110. review previously reported results using vitros nt-probnp reagent packs, lot 1110. according to the manufacturer, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 08 april 2014.

Device

vitros immunodiagnostic products nt-probnp calibrators, vitros immunodiagnostic products nt-probn...
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS Immunodiagnostic Products NT-proBNP Calibrators, VITROS Immunodiagnostic Products NT-proBNP Reagent Packs
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics