Events

Alerta De Seguridad para Plates for IVD Research - Prime Test Panel G

Según Ministry of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Lithuania que fue producido por Not specified.

¿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
  • Número del evento
    1
  • Fecha
    2018-05-18
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 recall data from the U.S. and Lithuania.
  • Notas adicionales en la data
  • Causa
    The name and address of the manufacturer of the medical device is not specified and the name and address of the manufacturer's authorized representative in the european economic area are not specified (not in compliance with the requirements of annex 1, paragraph 13.4.1 of the ivd regulation); the label provided on the medical device packaging indicates that the objective glass is coated with food or chemical substances, as well as the "see". instructions for use ', but not specified in the instructions for use, the instructions for use have not been included (not in compliance with the requirements of annex 1, points 13.4.2 and 13.1 of the ivd regulation).
  • Acción
    Do not allow to enter the Lithuanian market

Device

Plates for IVD Research - Prime Test Panel G

Manufacturer

Not specified
  • Representante del fabricante
    UAB Urmo Group
  • Source
    MH