Events

Retiro De Equipo (Recall) de Device Recall Access Thyroglobulin Antibody II, Part Number: A32898

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 Beckman Coulter 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
    57946
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1818-2011
  • Fecha de inicio del evento
    2011-01-26
  • Fecha de publicación del evento
    2011-03-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97800
  • 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
    Immunochemical, thyroglobulin autoantibody - Product Code JNL
  • Causa
    The recall was initiated after beckman coulter confirmed customer reports of reagent pack to pack variability for the access thyroglobulin antibody ii (tgab) reagent lot numbers identified in the recall. erroneous results for patient and quality control samples can be generated. the thyroglobulin antibody ii (tgabii) reagent lots may produce: (1) erroneously high tgab results for both quality co.
  • Acción
    Beckman Coulter sent a Product Corrective Action (PCA) letter on January 26, 2011 via US Postal Service to the affected customers. The letter explained the problem identified and the action to be taken. Customers were instructed to: (1) Discontinue use of Access Thyroglobulin Antibody II reagent lot numbers identified in the table above; (2) If customers obtained questionable thyroglobulin antibody results, or received feedback from clinicians on reported thyroglobulin antibody results using the reagent lot numbers identified above, rerun or request a redraw of the patient sample; (3) Share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they forwarded any of the affected product listed above to another laboratory, they should provide a copy of the letter to them; (4) Complete and return the enclosed response form within 10 days so the firm can be assured that you have received this important notification and are taking appropriate action. For questions regarding the recall communication, customers were told to contact Beckman Coulter Customer Support Center: (1) Via our website, http://www.beckmancoulter.com/customersupport/support (2) Via phone, call 1-800-854-3633 in the United States and Canada (3) Outside the United States and Canada please contact your local Beckman Coulter representative.

Device

Device Recall Access Thyroglobulin Antibody II, Part Number: A32898
  • Modelo / Serial
    Lot Number:  012741, 014751, 016551, 016838
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AR, CA, FL, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI and the countries of Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, France, French Polynesia, Georgia, Germany, Greece, Hungary, Israel, Italy, Kazakhstan, Kuwait, Lebanon, Morocco, Netherlands, New Zealand, Oman, Poland, Puerto Rico, Romania, Russian Federation, Serbia, South Africa, Spain, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Arab Emirates, Yemen
  • Descripción del producto
    Access Thyroglobulin Antibody II, Part Number: A32898 || The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Dirección del fabricante
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA