Events

Alerta De Seguridad para NeoBase Non-Derivatized Assay Solutions

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

¿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
    2015-03-02
  • Fecha de publicación del evento
    2015-03-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150302.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: perkinelmer neobase non-derivatized assay solutions medical device manufacturer, perkinelmer, has issued a medical device safety alert concerning its neobase non-derivatized assay solutions [product number: 3041-0020; lot number: 1063599401, 1063599501]. the manufacturer has become aware that some bottles used in the manufacturing of the neobase extraction solution (lots 634151 and 634247) and neobase flow solvent (lots 634152 and 634303), contained cardboard lint and red particles. bottles containing the aforementioned particles were used in the packaging of neobase non-derivatized assasy solutions kit lots 1063599401 and 1063599501. the particles can be visually detected by the human eye. the manufacturer has become aware that some bottles used in the manufacturing of the neobase extraction solution (lots 634151 and 634247) and neobase flow solvent (lots 634152 and 634303), contained cardboard lint and red particles. bottles containing the aforementioned particles were used in the packaging of neobase non-derivatized assasy solutions kit lots 1063599401 and 1063599501. the particles can be visually detected by the human eye. according to the manufacturer, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 march 2015.

Device

NeoBase Non-Derivatized Assay Solutions
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: PerkinElmer NeoBase Non-Derivatized Assay Solutions
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer