Events

Retiro De Equipo (Recall) de Accriva Diagnostic Inc. Activated Partial Thromboplastin Time cuvettes

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 Accriva Diagnostics Inc., dba ITC, dba Accumetrics.

¿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
    73949
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1720-2016
  • Fecha de inicio del evento
    2016-04-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145590
  • 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, multipurpose for in vitro coagulation studies - Product Code JPA
  • Causa
    Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing aptt test to either have an error code or an erroneously high result.
  • Acción
    Accriva sent an " Urgent Field Safety Notice" letter dated April 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to take the following actions: 1. Forward communication to all those within organization who need to be aware of this matter. In addition, forward notification to all other organizations where affected devices may have been transferred to. 2. Check inventory to determine if you have any APTT Test Cuvettes, Lot Number: B6JCA012 3. If have inventory of APTT Test Cuvettes, with the subject Lot Number destroy the product and submit the attached Destruction Form along with your request for credit. 4. If have inventory DO NOT SHIP TO CUSTOMERS any kits labeled with APTT Test Cuvettes and the subject Lot Number. 5. If have shipped this product to customers please inform them immediately to STOP using the product. Provide the customers with a copy of this notification, request for the destruction of any unused product and the return of the attached forms. 6. Follow the instructions on the attached Field Corrective Action Form, complete the form and return it as instructed on the form. 7. If have questions, please contact Accriva Diagnostics directly contact information is provided below. Accriva Diagnostic, Attn: Regulatory Affairs USA Tel: 858.263.2347 Email: Fieldaction16-007@accriva.com

Device

Accriva Diagnostic Inc. Activated Partial Thromboplastin Time cuvettes
  • Modelo / Serial
    Lot #B6JCA012
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.
  • Descripción del producto
    Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
  • Manufacturer
    Accriva Diagnostics Inc., dba ITC, dba Accumetrics

Manufacturer

Accriva Diagnostics Inc., dba ITC, dba Accumetrics
  • Dirección del fabricante
    Accriva Diagnostics Inc., dba ITC, dba Accumetrics, 6260 Sequence Dr, San Diego CA 92121-4358
  • Empresa matriz del fabricante (2017)
    Werfenlife Sa.
  • Source
    USFDA