Events

Retiro De Equipo (Recall) de Access AFP QC

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
    55678
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2208-2010
  • Fecha de inicio del evento
    2010-04-21
  • Fecha de publicación del evento
    2010-08-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91542
  • 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
    The recall was initiated after beckman coulter confirmed an issue with the access afp qc kits (ref 33219) which contain three levels of control material identified as qc1, qc2, and qc3, beckman coulter has confirmed that vials of qc1 in the kit lots identified above contain microbial contamination. customers may see that the results from a contaminated vial of qc1 are within the established refere.
  • Acción
    A Product Corrective Action (PCA) letter was sent on the week of April 19, 2010 to all customers who purchased the Access Immunoassay Systems AFP QC material, lot numbers referenced above. The letter provided the customers with an explanation of the problem identified and instructed the customers to (1) Please discard all remaining inventory of the three Access AFP QC kit lots identified above, including all vials of QC1, QC2, and QC3. (2) Please review your ac and patient results obtained while using the affected control lots. Interpret Access AFP test results in light of the clinical presentation of the patient, including: symptoms, clinical history, data from other tests and other appropriate information. (3) Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. (4) Complete and return the enclosed response form within 10 days so we can be assured that you have received this important notification. For customers that need assistance or have any questions regarding this notification, they were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada.

Device

Access AFP QC
  • Modelo / Serial
    Lot Numbers: 911158, 911581, and 917631
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada
  • Descripción del producto
    Access Immunoassay Systems AFP QC, Part Number: 33219 || The Access AFP QC is intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) 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