Events

Alerta De Seguridad para Calcium Gen.2 (CA2)

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Roche.

¿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
    2014-05-02
  • Fecha de publicación del evento
    2014-05-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140502.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: roche calcium gen.2 (ca2) medical device manufacturer, roche, has issued a field safety notice concerning calcium gen.2 (ca2). the affected catalogue numbers are 05061431190, 05061458190, 05061466190 and 05061474190. according to the manufacturer’s global complaint record, they received some customers complained of: duplicate and sens alarms during calibration, drop in quality control (qc) results , poor intermediate coefficient of variations (cv) for the ca2 (nm-bapta method) on the modular analytics analyzers. however, ca (gen.1) may seem to perform adequately. according to the manufacturer, it is assumed that the mentioned precision issue is due to the sensitivity of the ca2 assay to the maintenance condition of the modular analytics . on an analyzer maintained according to the manufacturer’s recommendations, the precision of ca2 should be within specifications. the manufacturer will implement a special hardware checking protocol to make sure the hardware condition of the system is satisfactory in the next preventative maintenance. furthermore, the manufacturer advises users to review their ca2 assay performance to see if they are affected by the mentioned symptoms. if users suspect that they are affected by the mentioned issue, the manufacturer advises them to perform a within run imprecision study (n=21) using qc materials for troubleshooting. the cv of the imprecision study should below 2%. then, users should contact the roche application representative with relevant data. according to the local supplier, 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 2 may 2014.

Device

Calcium Gen.2 (CA2)
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Roche Calcium Gen.2 (CA2)
  • Manufacturer
    Roche

Manufacturer

Roche