Retiro De Equipo (Recall) de ARCHITECT ® anti-HBs reagents

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
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  • 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
    On September 13, 2004, Abbott Diagnostics withdrew from the market. lots 17048M100 (per.07.04.05); 10014M200 (per.05.01.05); 09140M300 (per.17.10.04) and 08672M200 (per.16.10.04) of the reference 7C18-20. the lot 10014M201 (per.05.01.05) of the reference 7C18-2. and batches 13251M100 (per.01.06.05) and 10015M200 (per.06.01.05) of reference 7C18-3. of the in vitro diagnostic medical device called ARCHITECT ® anti-HBs reagents, following the detection of a stability problem that could lead to calibration failures, to non-standard quality control values ​​and sometimes to non-standard results. Discordant patients. This device allows the assay of anti-HBs antibodies (antibodies against hepatitis B virus surface antigen) in human serum or plasma, on the ARCHITECT automaton.


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  • 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