Retiro De Equipo (Recall) de Architect / Folates-Controls;Architect / Folates-Thinner Manual

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por ABBOTT DIAGNOSTIC.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    Abbott Diagnostic is withdrawing from the market. batches 94718M200 (per.31.01.04) and 04619M100 (per.28.06.04) of the in vitro diagnostic medical device called Architect / Folates-Controls - reference 6C12-1. and batches 07460M300 (per.18.06.04) and 11435M100 (per.08.09.04) of the in vitro diagnostic medical device known as Architect / Folates-Thinner Manual - reference 6C12-5. due to a lack of stability of human serum albumin in their composition; this defect may lead to lower than expected test results and lower than expected patient results for diluted samples only. Abbott Diagnostic informs affected users of the presence of the diluent in batch kits 06537M100; 09888M100; 06537M101; 05081M100; 07465M300 and 10587M200 of the in vitro diagnostic medical device called Architect / Folates Reagents - references 6C12-20; 6C12-25 and 6C12-30 and asks them, as a precaution, to no longer use the protocol "automatic dilution" with these lots .. These devices are intended for the determination of folate in serum, plasma and human erythrocytes on the Architect automaton. The results of this assay should be used in conjunction with other available data such as the results of other biological analyzes and clinical data.


  • Modelo / Serial
  • Descripción del producto
  • Manufacturer


  • 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