Events

Retiro De Equipo (Recall) de Device Recall VerifyNow IIb/IIIa Test

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
    67508
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1172-2014
  • Fecha de inicio del evento
    2014-02-13
  • Fecha de publicación del evento
    2014-03-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125633
  • 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
    Accumetrics is recalling the verifynow iib/iiia test because it may result in the reporting of an erroneous low platelet aggregation unit (pau) result. an erroneous low pau result may cause a low percent inhibition calculation or low baseline pau.
  • Acción
    Accumetrics sent an Urgent Medical Device Recall letter dated February 13, 2014 to all affected customers. The recall letter informs the customers of the problems identified and the actions to be taken. Cusotomers are instructed to complete the attached Customer Account Tracking Form and return it within 10 days by fax, email or mail. Customers with questions are instructed call Accumetrics Customer Support at (800) 643-1640 option 2 or email at support@accumetrics.com.

Device

Device Recall VerifyNow IIb/IIIa Test
  • Modelo / Serial
    Lot/Serial No.  WC0182B, WC0182C, WC0182A, WC0182D, WC0182E, WC0182F, WC0182G, WC0180C, WC0180E, WC0180F, WC0181A, WC0181C, WC0181D, WC0181F, WC0180A, WC0180B, WC0180D, WC0181B, WC0181E, WC0181G, WC0181H, WC0181J, WC0181K.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. || Product Usage: || The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow IIb/IIIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow Ilb/Illa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.
  • 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