Events

Retiro De Equipo (Recall) de Device Recall Cardiac Marker Control Calibration Verification Set

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 Point Of Care 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
    57742
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1864-2011
  • Fecha de inicio del evento
    2010-12-17
  • Fecha de publicación del evento
    2011-04-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97298
  • 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
    Single (Specified) Analyte Controls (Assayed and Unassayed) - Product Code JJX
  • Causa
    Presence of co2 in the head space of the vial can result in the generation of high results in cardiac marker control level 1, 2, and 3 which is used along with the cardiac marker control calibration verification set.
  • Acción
    Urgent Recall Notice letters with business reply cards were sent Fed ex on December 17, 2010 to all accounts. International notifications were sent on December 21, 2010. The letter identified the affected product and lot numbers along with a background explanation of the issue. The firm recommends that customers remove the cap from the vial; squeeze the vial 10 times, prior to thawing; replace cap on the vial; and then follow the remaining steps for use as outlines in section 14-12 of the i-STAT 1 System Manual. Customers are to complete and return the Business Reply card to acknowledge receipt of the letter. If the affected product had been further distributed then a copy of the letter should be provided to those customers as well. If additional information is needed, customers should contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or their Abbott Point of Care representative.

Device

Device Recall Cardiac Marker Control Calibration Verification Set
  • Modelo / Serial
    Cardiac Marker Control Calibration Verification Set - Lot number M10208
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02. || Used to verify the accuracy of results over the measurement range of the i-STAT cTnI test.
  • Manufacturer
    Abbott Point Of Care Inc.

Manufacturer

Abbott Point Of Care Inc.
  • Dirección del fabricante
    Abbott Point Of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • 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