Alerta De Seguridad para vitros immunodiagnostic products tsh calibrators; vitros immunodiagnostic products tsh 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
    2014-07-17
  • Fecha de publicación del evento
    2014-07-17
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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 tsh calibrators; vitros immunodiagnostic products tsh reagent packs medical device manufacturer, ortho clinical diagnostics, has issued a field safety notice concerning vitros immunodiagnostic products tsh calibrators (with product code 1487289) and vitros immunodiagnostic products tsh reagent packs (with product code 1912997). the affected products have a lot number of 4540 and an expiry date of 11 feb 2015. the manufacturer received complaints from some customers who were unable to generate a successful calibration using vitros tsh calibrators and reagent packs, lot 4540 on vitros 5600 and 3600 systems. the manufacturer has received no complaints of failed calibrations on the vitros eci/eciq system. furthermore, the manufacturer has confirmed that vitros tsh calibrators and reagent packs, lot 4540 may generate lower than expected calibrator level 1 signals on some vitros 5600 and vitros 3600 systems, resulting in a failed calibration due to an elevation in the ratio of signals for calibrator levels 1 and 2 (delta1). if the laboratory has a vitros eci/eciq system, users may continue to use vitros tsh calibrators and reagent packs, lot 4540 on the vitros eci/eciq system. any remaining inventory of lot 4540 is recommended to be used on the vitros eci/eciq system only. if the laboratory has a vitros 5600 and/or a vitros 3600 only: - users who have successfully calibrated vitros tsh calibrators and reagent packs, lot 4540 may continue using the current inventory until they have received the new product, provided that the tsh quality control results are acceptable. - to avoid experiencing this issue in the future, users should discontinue using and discard all vitros tsh calibrators and reagent packs, lot 4540 after receiving the new product. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 17 jul 2014.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS Immunodiagnostic Products TSH Calibrators; VITROS Immunodiagnostic Products TSH Reagent Packs
  • Manufacturer

Manufacturer