Events

Retiro De Equipo (Recall) de Device Recall ARCHITECT HAVABM Reagent

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 Diagnostics International, Ltd..

¿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
    55165
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1596-2010
  • Fecha de inicio del evento
    2009-12-30
  • Fecha de publicación del evento
    2010-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90201
  • 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
    Hepatitis A Test - Product Code LOL
  • Causa
    There is a potential to generate a false grayzone or reactive havab-m result when the architect ausab assay precedes the architect havab-m assay.
  • Acción
    Direct accounts (hospitals, private laboratories, and other institutions) were sent a Product Correction letter, dated 12/30/2009. The letter identified the affected product, explained the issue and patient impact, and listed several necessary actions. Customers were instructed to follow one of 4 different alternatives to protect the integrity of test results. The letter is to be retained for laboratory records and a copy should be sent to other laboratories that kits were forwarded to. Questions regarding this information should be directed to Customer Service at 1-877-4ABBOTT.

Device

Device Recall ARCHITECT HAVABM Reagent
  • Modelo / Serial
    Lot # 76175Q100 exp. date 4/18/10; Lot # 79412Q100 exp. date 7/22/10; Lot # 82584Q100 exp. date 10/20/10.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- Including Puerto Rico.
  • Descripción del producto
    ARCHITECT HAVAB-M Reagent || A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum.
  • Manufacturer
    Abbott Diagnostics International, Ltd.

Manufacturer

Abbott Diagnostics International, Ltd.
  • Dirección del fabricante
    Abbott Diagnostics International, Ltd., Carr # 2 Km 58.0, Cruce Davila, Barceloneta PR 00617
  • 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