Events

Alerta De Seguridad para Ebola Virus One Step Test Kits

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

¿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
    2015-04-17
  • Fecha de publicación del evento
    2015-04-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150417a.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: lusys laboratories ebola virus one step test kits the united states food and drug administration (fda) has issued medical device safety alerts concerning various ebola virus one step test kits, manufactured by lusys laboratories, inc. the affected devices are identified as follow:- ebola virus antigen blood, catalog no. i-123 (a). ebola virus gp-vp igs, catalog no. i-124. ebola accessories assembled, self-contained package, catalog no. i-104. [lot no. dei007963] ebola virus antigen nasal , catalog no. i-123 (b). [lot no. 12292014b] ebola igx vp-40 serum/plasma/blood cassette, catalog no. i-100. [lot no. 12012014b] ebola gp igx blood, serum, plasma, cassette, catalog no. i-101. [lot no. 12012014b] ebola gp igm blood (blood serum/plasma/cassette), catalog no. i-103. [lot no. 12012014a] ebola vp-40 igg/igm (blood serum/plasma/cassette), catalog no. i-102.[lot no. 11192014b] the manufacturer is recalling the above ebola virus test kits as they have not yet been cleared, approved or authorised by the fda for diagnostics purposes. for details, please refer to the fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=70668&w=04152015%e2%8c%a9=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 april 2015.

Device

Ebola Virus One Step Test Kits
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: LuSys Laboratories Ebola Virus One Step Test Kits
  • Manufacturer
    LuSys Laboratories

Manufacturer

LuSys Laboratories