Events

Alerta De Seguridad para vitros 25-oh vitamin d total calibrators

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
    2014-01-29
  • Fecha de publicación del evento
    2014-01-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140129.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 25-oh vitamin d total calibrators medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its vitros 25-oh vitamin d total calibrators [product code: 6842893; lot numbers: 0091 through 0235]. the manufacturer has found that the vitros immunodiagnostic product 25-oh vitamin d total calibrators, lots 0091 through 0235, used with vitros immunodiagnostic products 25-oh vitamin d total reagent packs, may generate negatively biased results the manufacturer advises all affected users to immediately discard all current lots of vitros immunodiagnostic product 25-oh vitamin d total calibrators and reagent packs (lots 0200, 0210, 0220, 0230 and 0235). affected users are also instructed to review previously reported results generated using vitros immunodiagnostic product 25-oh vitamin d total calibrators, lots 0091 through 0235. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 january 2014.

Device

vitros 25-oh vitamin d total calibrators
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS 25-OH Vitamin D Total Calibrators
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics