Events

Notificaciones De Seguridad De Campo acerca de Architect Intact PTH Reagent Kit, Architect Intact PTH Controls, Architect Intact PTH Calibrators

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por Abbott GmbH & Co..

¿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
    2014-11-02
  • Fecha de publicación del evento
    2014-02-28
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2014/02/28/6168/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    The results obtained using the affected batches may be falsely elevated and that may indicate a positive shift over the results obtained. using previous batches of reagents and / or calibrators. this shift may affect reference intervals of the architect intact pth test determined in a particular laboratory, whereby abbott architect intact pth controls do not detect displacement. as regards the diagnosis of diseases related to disorders of calcium metabolism, these false elevated results may lead the doctor to think that the patient is suffering from hyperparathyroidism, or to fail to diagnose hypoparathyroidism. these findings would be inconsistent with the clinical picture and / or with the results of other tests and could lead to new patient testing and short-term placement delays diagnoses in chronic diseases.

Device

Architect Intact PTH Reagent Kit, Architect Intact PTH Controls, Architect Intact PTH Calibrators
  • Modelo / Serial
    ARCHITECT Intact PTH 8K25-01 Calibrator 006131000 05 SEP 2014 ARCHITECT Intact PTH 8K25-01 Calibrator 01913C000 14 MAR 2014 ARCHITECT Intact PTH 8K25-01 Calibrator 01913K000 12 NOV 2014 ARCHITECT Intact PTH 8K25-01 Calibrator 02413E000 09 MAY 2014 ARCHITECT Intact PTH 8K25-01 Calibrator 01312K000 12 NOV 2013 ARCHITECT Intact PTH 8K25-01 Calibrator 00813AOOO 08 JAN 2014 ARCHITECT Intact PTH 8K25-01 Calibrator 01412H000 16 AUG 2013 ARCHITECT Intact PTH 8K25-01 Calibrator 00912F000 30 MAY 2013 ARCHITECT Intact PTH 8K25-10 Control 007131000 05 SEP 2014 ARCHITECT Intact PTH 8K25-10 Control 01813C000 14 MAR 2014 ARCHITECT Intact PTH 8K25-10 Control 01813K000 12 NOV 2014 ARCHITECT Intact PTH 8K25-10 Control 02613E000 09 MAY 2014 ARCHITECT Intact PTH 8K25-10 Control 01412K000 12 NOV 2013 ARCHITECT Intact PTH 8K25-10 Control 00713A000 08 JAN 2014 ARCHITECT Intact PTH 8K25-10 Control 01012F000 30 MAY 2013 ARCHITECT Intact PTH 8K25-20 Reagent 00913F000 23 NOV 2014 ARCHITECT Intact PTH 8K25-20 Reagent 01313C000 21 AUG 2014 ARCHITECT Intact PTH 8K25-20 Reagent 01512K000 25 APR 2014 ARCHITECT Intact PTH 8K25-20 Reagent 01712H000 23 FEB 2014 ARCHITECT Intact PTH 8K25-20 Reagent 018131000 13 MAR 2015 ARCHITECT Intact PTH 8K25-20 Reagent 02213K000 08 MAY 2015 ARCHITECT Intact PTH 8K25-20 Reagent 01312G000 13 JAN 2014 ARCHITECT Intact PTH 8K25-20 Reagent 00512H000 13 JAN 2014 ARCHITECT Intact PTH 8K25-25 Reagent 00112K000 25 APR 2014 ARCHITECT Intact PTH 8K25-25 Reagent 01113C000 21 AUG 2014 ARCHITECT Intact PTH 8K25-25 Reagent 01313G000 05 JAN 2015 ARCHITECT Intact PTH 8K25-25 Reagent 01612H000 23 FEB 2014 ARCHITECT Intact PTH 8K25-25 Reagent 019131000 02 FEB 2015 ARCHITECT Intact PTH 8K25-25 Reagent 02213D000 05 OCT 2014 ARCHITECT Intact PTH 8K25-25 Reagent 00113K000 11 APR 2015 ARCHITECT Intact PTH 8K25-25 Reagent 01212G000 13 JAN 2014 ARCHITECT Intact PTH 8K25-25 Reagent 00412H000 13 JAN 2014 ARCHITECT Intact PTH 8K25-27 Reagent 00212K000 25 APR 2014 ARCHITECT Intact PTH 8K25-27 Reagent 01213C000 21 AUG 2014 ARCHITECT Intact PTH 8K25-27 Reagent 01413G000 05 JAN 2015 ARCHITECT Intact PTH 8K25-27 Reagent 01812H000 23 FEB 2014 ARCHITECT Intact PTH 8K25-27 Reagent 020131000 02 FEB 2015 ARCHITECT Intact PTH 8K25-27 Reagent 02313D000 05 OCT 2014 ARCHITECT Intact PTH 8K25-27 Reagent 00213K000 11 APR 2015 ARCHITECT Intact PTH 8K25-27 Reagent 01412G000 13 JAN 2014 ARCHITECT Intact PTH 8K25-27 Reagent 00612H000 13 JAN 2014
  • Manufacturer
    Abbott GmbH & Co.

Manufacturer

Abbott GmbH & Co.
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ALIMSA