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-1853-2012
  • 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=108939
  • 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
    Lot # WK0002A WK0003A WK0003B WK0004A WK0005A WK0006A WK0006B WK0006AR WK0006BR WK0007A WK0008A WK0009A WK0010A WK0010B WK0010C WK0011A WK0012A WK0013A WL0001A WL0001B WK0014A WK0015A WL0003A WL0004A WK0016A WL0005A WL0006A WL0007A WK0017A WK0018A WL0007B WL0008A WK0018B WK0018-5A WL0008-5A WL0009A WL0009-5A WK0019A WL0009B WL0010A WL0010-5A WL0010B WL0011-5A WL0011A WL0013A WL0012A WL0012-5A WL0015-5A WL0015A WL0016-5A WL0016A WL0017A WL0018A WL0018-5A WL0019A WL0020A WL0020-5A WL0018B WK0020A WL0021A WL0022A WL0023A WL0023-5A WL0024A WL0024B WL0025A WL0026A WL0026A WL026-5A WL0027 WL0028 WL0029 WL0029A WL0029B WL0030 WL0031 WL0030A WL0033 WL0034 WL0035 WL0036 WL0038 WL0033A WL0039 WL0040 WL0040A WL0041 WL0042 WL0043 WL0044 WL0045 WL0046 WL0045A WL0049 WL0049A WL0051 WL0051A WL0052 WL0053 WL0055 WL0056 WL0057 WL0057A WL0059 WL0060 WL0061 WL0061A WL0062 WL0062A WL0061A WL0063 WL0062B WL0064 WL0065 WL0067 WL0069 WL0070 WL0071 WL0066A WL0068A WL0072 WL0073 WL0074 WL0075 WL0076 WL0078 WL0079 WL0080 WL0081 WL0076A WL0082 WL0083 WL0084 WL0088 WL0089A WL0091 WL0090 WL0093 WL0097 WL0098 WL0099 WL0101 WL0102 WL0105 WL0106 WL0108 WL0111 WL0111A WL0113 WL0117 WL0118
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. || 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