Events

Retiro De Equipo (Recall) de Device Recall VerifyNow IIb/IIIa Test, 10Test Kit

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
    66834
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0482-2014
  • Fecha de inicio del evento
    2013-11-14
  • Fecha de publicación del evento
    2013-12-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123688
  • 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 10-test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. the correct instruction is to perform the test within 15 minutes of collecting the patient sample.
  • Acción
    Accumetrics sent an Urgent Medical Device Correction letter dated November 14, 2013 to end users for the VerifyNow IIb/IIIa 10-Test. The letter informs the customers of the problems identified and the actions to be taken. The customers are instructed to call Accumetrics Customer Support at (800) 643-1640 option 2 or email at support@accumetrics.com. Customers are instructed to complete and return the enclosed Customer Account Tracking Form as soon as possible. For questions regarding this recall call 858-643-1600.

Device

Device Recall VerifyNow IIb/IIIa Test, 10Test Kit
  • Modelo / Serial
    Lot No. WC0181H, WC0181J, WC0181K
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including NY, PA, DC, CT, IN, NJ, AR, TX, AZ,and NM.
  • Descripción del producto
    VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, || 10 tests/box; 690 total tests. || The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow lIb/IlIa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. 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 lIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide.
  • 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