Events

Retiro De Equipo (Recall) de Device Recall ARCHITECT HBsAg Qualitative Assay, ARCHITECT HBsAg Qualitative Confirmatory Assay

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Abbott Laboratories, Inc.

¿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
    63946
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0987-2013
  • Fecha de inicio del evento
    2012-12-18
  • Fecha de publicación del evento
    2013-03-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115090
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
  • Causa
    Abbott has identified that assay files for the architect hbsag qualitative and hbsag qualitative confirmatory assays (lns 4p53 and 4p54) on the architect i1000sr system were mistakenly made available on abbottdiagnostics.Com in october 2012. additionally, some i1000sr customers received notification through abbottlink in november 2012 that assay files for lns 4p53 and 4p54 were available. the ar.
  • Acción
    The firm decided to correct the issue and and sent out Urgent Field Safety Notices to their customers dated 10/18/2012.

Device

Device Recall ARCHITECT HBsAg Qualitative Assay, ARCHITECT HBsAg Qualitative Confirmatory Assay
  • Modelo / Serial
    All shipped out to this date
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.
  • Descripción del producto
    ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 || The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • Dirección del fabricante
    Abbott Laboratories, Inc, 1921 Hurd Dr, Irving TX 75038-4313
  • 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
    USFDA