Events

Notificaciones De Seguridad De Campo acerca de IMMULITE®/IMMULITE® 1000 IMMULITE® 2000/IMMULITE® 2000 XPi Assays

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 Siemens Healthcare Diagnostics GmbH.

¿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
    2017-12-22
  • 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
    2000 xpi assays listed in table 1 are susceptible to biotin interference. this occurs when biotin present in patient samples interferes with the biotin-streptavidin assay architecture on the immulite platform. biotin interference has the potential to bias analytical results on the assays listed above. the instructions for use (ifu) currently do not list biotin as a potential interferant. concentrations of biotin above the concentration listed in table 2 can potentially result in interference greater than 10%, leading to either falsely elevated or falsely depressed results. .

Device

IMMULITE®/IMMULITE® 1000 IMMULITE® 2000/IMMULITE® 2000 XPi Assays
  • Modelo / Serial
    3gAllergy™ Specific IgE Universal Kit IMMULITE 2000/IMMULITE 2000 XPi L2KUN6 L2KUNJ6 10380875 10711939 Anti HBc IMMULITE 2000/IMMULITE 2000 XPi L2KHC2 10381311 BR-MA (CA15-3) IMMULITE/IMMULITE 1000 LKBR1 10380948 BR-MA (CA15-3) IMMULITE 2000/IMMULITE 2000 XPi L2KBR2 10380983 CEA IMMULITE/IMMULITE 1000 LKCE1 10380945 CEA IMMULITE 2000/IMMULITE 2000 XPi L2KCE2 L2KCE6 10380994 10380995 CK-MB IMMULITE/IMMULITE 1000 LKMB1 10381016 CK-MB IMMULITE 2000/IMMULITE 2000 XPi L2KMB2 10381033 EPO IMMULITE/IMMULITE 1000 LKEPN1 10487627 EPO IMMULITE 2000/IMMULITE 2000 XPi L2KEPN2 L2KEPN6 10487628 10487629 SIEMENS Folic Acid IMMULITE 2000/IMMULITE 2000 XPi L2KFO2 L2KFO6 10380911 10380912 Gastrin IMMULITE/IMMULITE 1000 LKGA1 10380962 Gastrin IMMULITE 2000/IMMULITE 2000 XPi L2KGA2 10380979 OM-MA (CA125) IMMULITE/IMMULITE 1000 LKOP1 10380969 OM-MA (CA125) IMMULITE 2000/IMMULITE 2000 XPi L2KOP2 10380972 Thyroglobulin IMMULITE/IMMULITE 1000 LKTY1 10381644 Thyroglobulin IMMULITE 2000/IMMULITE 2000 XPi L2KTY2 10381648 Vitamin B12 IMMULITE/IMMULITE 1000 LKVB1 10380900 Reason for Correction Siemens Healthcare Diagnostics has confirmed through internal investigation that the IMMULITE ® /IMMULITE ® 1000/IMMULITE ® 2000/IMMULITE
  • Manufacturer
    Siemens Healthcare Diagnostics GmbH

Manufacturer

Siemens Healthcare Diagnostics GmbH
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    AMPMDRS