Events

Notificaciones De Seguridad De Campo acerca de ARCHITECT Intact PTH Assay Reagents, Calibrators and Controls

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Abbott Laboratories.

¿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
  • Número del evento
    SN2014(05)
  • Fecha
    2014-02-21
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/architect-intact-pth-assay-reagents-calibrators-and-controls&id=7978f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    Abbott has confirmed that a performance shift in the architect intact parathyroid (pth) assay has the potential to generate falsely elevated results on patient samples.  this issue affects architect intact pth assay list number 8k25, reagents (8k25-20, 8k25-25, 8k25-27*), calibrators (8k25-01) and controls (8k25-10). refer to attached field safety notice (fsn).  the scope of the issue affects devices manufactured between may 2012 and november 2013.  *note: this list number is not ce-marked and is distributed to usa and puerto rico only.
  • Acción
    Abbott has launched a product recall for affected lots of ARCHITECT Intact PTH assay reagents, calibrators and controls and has issued a FSN to provide instructions on what actions your laboratory must take (as follows):  - Immediately discontinue use of, and destroy, any remaining inventory of ARCHITECT Intact PTH assay according to your laboratory procedures.  - To continue Intact PTH testing at your laboratory, Abbott recommends that you identify an alternate method for testing patient samples. If further guidance is needed, please contact your Abbott sales representative.  - This letter should be reviewed with the treating physician or healthcare provider to ensure they are aware of the issue and can determine whether re-evaluation of the patient is necessary.  - If you have forwarded any product to other laboratories, please inform them of this FSN.  The IMB recommends that results with the ARCHITECT Intact PTH assay are reviewed as appropriate to determine whether re-evaluation of the patient is necessary.  Please forward this safety notice to all those who need to be aware of this action within your organisation and to maintain awareness over this safety notice for an appropriate time period.

Device

ARCHITECT Intact PTH Assay Reagents, Calibrators and Controls
  • Modelo / Serial
  • Descripción del producto
    ARCHITECT Intact PTH Assay Reagents, Calibrators and Controls
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • 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
    HPRA