Events

Retiro De Equipo (Recall) de Device Recall EVOLIS Assay Protocol Files ( APF) Software

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 Bio-Rad Laboratories.

¿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
    56389
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2201-2011
  • Fecha de inicio del evento
    2010-07-19
  • Fecha de publicación del evento
    2011-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93387
  • 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 linked immunoabsorbent assay, rubella - Product Code LFX
  • Causa
    The evolis assay protocol files software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.
  • Acción
    Bio-Rad Laboratories sent an Urgent Product Correction letter dated July 19, 2010, to all customer sites via FedEx. There are two issues related to The EVOLIS Assay Protocol Files (APF) Software that could potentially affect patient results. Issue 1 involves quantitative sample test/calculations/results interpretation for assays with linear regression, point to point or 4PL data reduction. Issue 2 involves sample test results with " Result Report Flags''. A software patch to correct these two issues will be sent to each customer site. Bio-Rad Laboratories will work with each customer to complete documentation confirming that the software patch has been successfully installed on each instrument. If you have any questions or concerns regarding these two issues, please contact Technical Support at 1-800-224-6723, option 2 and then option 3.

Device

Device Recall EVOLIS Assay Protocol Files ( APF) Software
  • Modelo / Serial
    APF Version 4.4 Software Version 2.00 2009/05 LOT=V4.4-0505-2
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- Including Puerto Rico.
  • Descripción del producto
    Software CD is labeled in part: || "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***" || The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data reduction and generate reports.
  • Manufacturer
    Bio-Rad Laboratories

Manufacturer

Bio-Rad Laboratories
  • Dirección del fabricante
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • Empresa matriz del fabricante (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA