Events

Retiro De Equipo (Recall) de Device Recall Access Immunoassay Systems Total T4 Calibrators

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
    59239
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3027-2011
  • Fecha de inicio del evento
    2010-08-26
  • Fecha de publicación del evento
    2011-08-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101937
  • 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
    Enzyme immunoassay, non-radiolabeled, total thyroxine - Product Code KLI
  • Causa
    The recall was initiated because beckman coulter has confirmed that the stability claims for the access total t4 calibrators may not be met. this issue is associated with calibrator lots 917074 and 008534.
  • Acción
    Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated September 13, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue use of the affected lot numbers and review historical quality control performance. Additionally, a response form was attached to the letter for customers to complete and return. Alternate lots will be provided for current and future replenishment orders or requests. Customers with questions regarding this notification can call Technical Support at (800) 854-3633 or contact their local Beckman Coulter representative.

Device

Device Recall Access Immunoassay Systems Total T4 Calibrators
  • Modelo / Serial
    Lot Number: 917074, 008534  Expiration Date: 917074 (12/31/10), 008534 (2/28/11)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • Descripción del producto
    Access¿ Immunoassay Systems Total T4 Calibrators, || Part Number: 33805, || Subsequent Product Code: JIS || The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) 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., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA