Retiro De Equipo (Recall) de ARCHITECT I SYSTEM - DHEA-S ASSAY

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Abbott has identified that falsely elevated results may be obtained when using the architect dhea-s assay with samples from infants up to 60 days old. the specific cause of the elevated results is currently under investigation. although falsely elevated results have only been observed with samples from infants up to 60 days old the expected values representative data for children up to 10 years old provided in the architect dhea-s reagent insert should not be used as these reference ranges are being reviewed as part of the investigation. all in-date lots of current reagent inventory are impacted.


  • Modelo / Serial
    Model Catalog: 8K27-25 (Lot serial: 01217A000); Model Catalog: 8K27-25 (Lot serial: 02217D000); Model Catalog: 8K27-25 (Lot serial: 01316K000); Model Catalog: 8K27-20 (Lot serial: 02217D000); Model Catalog: 8K27-25 (Lot serial: 04117H000); Model Catalog: 8K27-20 (Lot serial: 04117H000); Model Catalog: 8K27-25 (Lot serial: 01216K000); Model Catalog: 8K27-20 (Lot serial: 01216K000); Model Catalog: 8K27-25 (Lot serial: 02817H000); Model Catalog: 8K27-25 (Lot serial: 01117A000); Model Catalog: 8K27-20 (Lot serial: 01117A000); Model Catalog: 8K27-25 (Lot serial: 02217C000); Model Catalog: 8K27-20 (Lot serial: 02217C000); Model Catalog: 8K27-25 (Lot serial: 02317D000); Model Catalog: 8K27-20 (Lot serial: 02317D000); Model Catalog: 8K27-25 (Lot serial: 02417D000); Model Catalog: 8K27-20 (Lot serial: 02417D000); Model Catalog: 8K27-25 (Lot serial: 00517F000); Model Catalog: 8K27-20 (Lot serial: 02817H000); Model Catalog: 8K27-20 (Lot serial: 00517F000); Model Catalog: 8K27-20 (Lot serial: 01217A000); Model Catalog:
  • Descripción del producto
  • Manufacturer


  • Dirección del fabricante
  • Empresa matriz del fabricante (2017)
  • 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