Events

Notificaciones De Seguridad De Campo acerca de INSTI® HIV-1/HIV-2 Antibody Test

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Laboratoires NEPHROTEK.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-02-02
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Three false negative results were reported by a customer when testing three different patient samples with insti hiv-1/hiv-2 antibody test kit from lot 1512ba033. all customers that received the insti hiv-1/hiv-2 antibody test kit lot 1512ba033 were initially advised (by means of field safety notice ai002.17.N, dated 19 january 2017) to quarantine any kits from this lot remaining in their inventory. biolytical laboratories inc. the manufacturer of insti hiv-1/hiv-2 antibody test conducted a thorough investigation using the insti kits from lot 1512ba033 that were retained at the manufacturer’s facility and sample kits returned by the complainant. sera samples of the patients that tested false negative with insti kits from lot 1512ba033 were also used by biolytical laboratories inc. to conduct the investigation. .

Device

INSTI® HIV-1/HIV-2 Antibody Test

Manufacturer

Laboratoires NEPHROTEK