Events

Retiro De Equipo (Recall) de ARCHITECT I - 2ND GENERATION TESTOSTERONE REAGENT

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
    Recall
  • ID del evento
    94615
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-03-09
  • País del evento
    Canada
  • Fuente del evento
    HC
  • 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
    On february 24 2016 a product deficiency was identified. testing performed to investigate complaint ticket 1061060r1715901 (received february 12 2016) confirmed the issue of obtaining the message "no assay" on the architect module display when using the new assay file and testing with architect 2nd generation testosterone reagent kit list number 2p13-28 lot 10458up00. a non-conformance report was opened on 24feb2016. preliminary root cause investigation was performed by tpm axis-shield diagnostics and identified the barcode for this lot was coded with the us assay file number instead of the ous assay file number. the information is hardcoded to the barcode on the microparticle bottle. therefore the customers are unable to test because the ous assay file does not recognize this lot with us assay file. axis shield has both assay files (us and ous) installed on their analyzer which is why the lot passed testing during manufacturing.

Device

ARCHITECT I - 2ND GENERATION TESTOSTERONE REAGENT

Manufacturer

ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION
  • Dirección del fabricante
    MISSISSAUGA
  • 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
    HC