Events

Retiro De Equipo (Recall) de Device Recall VERIFYNOWP2Y12 ASSAY

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 Accumetrics 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
    61761
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1854-2012
  • Fecha de inicio del evento
    2012-02-06
  • Fecha de publicación del evento
    2012-06-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109704
  • 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
    System, automated platelet aggregation - Product Code JOZ
  • Causa
    The recall was initiated by accumetrics because of a field correction to the verifynow system; specifically the results reported when running the verifynow p2y12 test. currently the verifynow p2y12 test reports three values: pru, base and % inhibition. the change implemented is the elimination of the base and % inhibition results. there will be no change to the reporting of the pru result whic.
  • Acción
    Accumetrics, Inc. sent an Urgent Field Correction notification letter and an Ackknowledgement - fax back form to all affected customers. The letter identifed the affected product, problem and actions to be taken. The letter informed customers that an Accumetrics representative will be contacting them to schedule an appointment to update their VerifyNow instrument software. The letter stated that Accumetrics realizes that procedures and report format may need to be revised as software changes is implemented, and will provide assistance to help in making this transition. For any questions or concerns, call at 1-800-643-1640 ext. 2; or email at: support@accumetrics.com.

Device

Device Recall VERIFYNOWP2Y12 ASSAY
  • Modelo / Serial
    Not available
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    VerifyNow System, part #85005-6H || Product Usage: || The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
  • Manufacturer
    Accumetrics Inc

Manufacturer

Accumetrics Inc
  • Dirección del fabricante
    Accumetrics Inc, 3985 Sorrento Valley Blvd Ste B, San Diego CA 92121-1497
  • Empresa matriz del fabricante (2017)
    Werfenlife Sa.
  • Source
    USFDA