Events

Alerta De Seguridad para Calibration Data Module

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
    2014-02-07
  • Fecha de publicación del evento
    2014-02-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140207a.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 calibration data module medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its calibration data module (cdm prom) [affected lot: 0168 catalogue number: 1999077]. a cdm prom is an electronic device that contains data required to perform various tests on the vitros dt60/dt60 ii chemistry systems. according to the manufacturer, this product correction notification has been initiated due to an inability to calibrate or use vitros crsc dt slides, gen 82 when using cdm prom 0168. calibration data module (cdm prom) 0168 contains data that allows the use of new lots of vitros dt slides and vitros dt calibrator kits on vitros dt60/dt60 ii chemistry systems. this cdm prom was sent to all customers beginning in october 2013. the manufacturer has received complaints for the inability to calibrate or subsequently use vitros crsc dt slides, gen 82 after the installation of cdm prom 0168. according to the local supplier, 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 07 february 2014.

Device

Calibration Data Module
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ortho Clinical Diagnostics Calibration Data Module
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics