Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia 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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 156 07 18 001
  • Fecha de inicio del evento
    2018-10-21
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13363
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR, FDA
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The purpose of this communication is to inform you of an issue with the products indicated in table 1 above and provide instructions on actions for your laboratory to take. siemens healthcare diagnostics has identified a bias with advia centaur ckmb calibrator kit lots ending in 64 (ck64) when compared to internal standards and previously released advia centaur ckmb calibrator kit lots ending in 63 (ck63) on the advia centaur/xp/xpt and advia centaur cp systems. the patient sample bias observed when comparing advia centaur ckmb calibrator kit lots ending in 64 to unaffected advia centaur ckmb calibrator kit lots ending in 63 is found in table 2, figure 1 and figure 2. alignment to the internal standardization is restored with the release of advia centaur ckmb calibrator kit lots ending in 68 (ck68). customers may observe a shift in quality control (qc) material, master curve material (mcm) and patient results when transitioning from advia centaur ckmb calibrator lots ending in 64. refer to the additional information section for information related to patient sample bias and bio-rad controls. siemens has also identified the potential for out of range advia centaur ckmb master curve material results when using the lot identified in table 1 on the advia centaur/xp/xpt and advia centaur cp systems. the root cause is currently under investigation.

Device

ADVIA Centaur CKMB Calibrator Bias and Out of Range Results Using Master Curve Material (MCM)
  • Modelo / Serial
    ADVIA Centaur CKMB Calibrator : 09318028 : 10311570 Lot : 57834A64, 57835A64, 72519A64, 98115A64 ADVIA Centaur CKMB MCM : 07867768 : 10309782 Lot: 35061 ......................................... FDA update codes: ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 SMN 10333512 Lot # Expiry UDI # 58311A67 2018-Dec-11 (01)00630414056890(10)58311A67(17)20181211 97468A67 2018-Dec-11 (01)00630414056890(10)97468A67(17)20181211 Atellica IM CKMB Master Curve Material, Cat No. 10995534 SMN 10995534 Lot # Expiry UDI # 11803 2019-02-10 (01)00630414598611(10)11803(17)20190210 Atellica IM CKMB Calibrator, Cat No. 10995532 SMN 10995532 Lot # Expiry UDI # 57837A66 2018-12-11 (01)00630414598598(10)57837A66(17)20181211 67443A66 2018-12-11 (01)00630414598598(10)67443A66(17)20181211
  • Descripción del producto
    IVDs
  • Manufacturer
    Siemens Healthcare Diagnostics GmbH

Manufacturer

Siemens Healthcare Diagnostics GmbH
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Representante del fabricante
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA