Events

Alerta De Seguridad para IVD diagnostic test kits (Allergen (egg white) rapid test device, Milk Allergy test device, Shrim (F24) Allergy Rapid test device, Dust Mite test device, Allergen (Cat dander) Rapid test device, Dog Dander Allergy test device, Oak white Allergy test device, Mugwort Allergy test device, Allergen (Ragweed) Rapid test device, Syphilis Rapid test device)

Según Ministry of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Lithuania que fue producido por Assuro Tech. (Hangzhou) Ltd., China.

¿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
    2
  • Fecha
    2018-06-12
  • 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
    All instructions for use attached to the ivd tests do not bear the ce conformity marking - do not meet the requirements of point 61 of the ivd regulation; name and address of the manufacturer's authorized representative in the european economic area not specified in the package leaflet accompanying the ivd tests peanut allergy test device, dust mite test device, outer packaging and individual test packaging - not in accordance with annex 1, 13.4.1 of the ivd regulation requirements; lancets in ivd diagnostic test kits for finger puncture and blood sampling for ivd testing, without ce marking, no manufacturer and address, no manufacturer's authorized representative in the european economic area, no batch / serial number, non-sterile medical device (unpacked) it is not possible to separate the lancet according to the lancet structure in a separate package to ensure sterility, lancet has not been used), no information has been added that it should be sterilized before use of the lancet and no indication is given that the measure is intended for single use. can be safely used - does not meet the requirements of mp 39 and annex 1, paragraph 9, 14.3.1, 14.3.3, 14.3.4, 14.3.5, 14.3.614.3.10.
  • Acción
    Do not allow to enter the Lithuanian market

Device

IVD diagnostic test kits (Allergen (egg white) rapid test device, Milk Allergy test device, Shrim...

Manufacturer

Assuro Tech. (Hangzhou) Ltd., China
  • Representante del fabricante
    UAB East Scandinavia Company
  • Source
    MH