Events

Alerta De Seguridad para Blood Grouping Reagent MTS A/B/D Monoclonal and Reverse Grouping Card

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
    2014-07-28
  • Fecha de publicación del evento
    2014-07-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140728.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 blood grouping reagent mts a/b/d monoclonal and reverse grouping card medical device safety alert: ortho clinical diagnostics blood grouping reagent mts a/b/d monoclonal and reverse grouping card the manufacturer observed an increased number of complaints related to false positive and/or reactions containing haze in the anti-a and buffered gel micro-tubes used for reverse abo typing in the mts a/b/d monoclonal and reverse grouping card lots listed above. investigation by the manufacturer determined that the false positive reactions were due to broken gel beads in the micro-tubes of the mts cards. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the following health canada website: http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/40629r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 july 2014.

Device

Blood Grouping Reagent MTS A/B/D Monoclonal and Reverse Grouping Card
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ortho Clinical Diagnostics Blood Grouping Reagent MTS A/B/D Monoclonal and Reverse Grouping Card
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics