Events

Retiro De Equipo (Recall) de Device Recall Simplastin Excel

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 Biomerieux, 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
    25587
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0629-03
  • Fecha de inicio del evento
    2003-02-04
  • Fecha de publicación del evento
    2003-03-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-01-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26108
  • 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
    Test, Time, Prothrombin - Product Code GJS
  • Causa
    Product is being recalled due to vial to vial variability of clotting time results.
  • Acción
    Consignees were notified by a Customer Notification letter sent via regular mail on/about February 4, 2003 with response form attached. An additional cover letter was sent to international affiliates/distributors who were responsible for notifying their customers. Consignees were asked to report the amount of product on hand and to destroy the product. On March 18th the firm expanded the recall. Consignees were notified by letter on March 19th , and March 31, 2003 and were advised to stop using the affected lot numbers, destroy the remaining material in inventory and to contact their local bioMerieux Customer Service representative for replacement.

Device

Device Recall Simplastin Excel
  • Modelo / Serial
    Lot numbers: 161402, 161431, 161432, 161477, 161448, 161479, 161507, 161508, 161550, 161551, 161583, 161585, 161595, 161657, 161658. Expanded 3/19/2003 to include lot #161639, 16160 and 1611711. Final expansion of recall initiated 5/30/2003 to include Product Number 252001 (20ml), lot numbers161403, 161480, 161509, 161510, 161552 161586 and 161596.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was distributed nationwide and Brazil, Canada, China, Japan, Korea, Mexico, The Netherlands, Taiwan, Venezuela
  • Descripción del producto
    Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. Durham, NC 27704. The product consists of two vials, a thromboplastin reagent and a diluent ( the vials are mixed together before use).
  • Manufacturer
    Biomerieux, Inc.

Manufacturer

Biomerieux, Inc.
  • Dirección del fabricante
    Biomerieux, Inc., 100 Rodolphe Street, Durham NC 27712
  • Source
    USFDA