Events

Notificaciones De Seguridad De Campo acerca de LIFECODES HLA-DQA1/B1 Typing Kit

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 Immucor.

¿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
    2015-12-30
  • 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
    We are investigating a single instance of false positive reactivity of probe dqb253 associated with an allele pair of dqb1*03:03:02:01, dqb1*03:04:01. a false positive result causes the exclusion of dqb1*03:03:02:01/ 03:04:01 as a possible allele combination. the risk to the patient is considered low due to the low frequency of this event, and the additional risk reduction achieved through application of the requirements and limitations described in the product insert. results from these kits are not to be used as the sole basis upon which a clinical decision affecting the patient is made. due to the complex nature of hla typing, qualified personnel should review data interpretation and typing assignments, as per the limitations of the procedure section of the product insert. .

Device

LIFECODES HLA-DQA1/B1 Typing Kit
  • Modelo / Serial
  • Manufacturer
    Immucor

Manufacturer

Immucor
  • Empresa matriz del fabricante (2017)
    Grifols Sa
  • Source
    AMPMDRS