Events

Retiro De Equipo (Recall) de Device Recall Wako Autokit Lp(a) Calibrator

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 Wako Chemicals USA, 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
    61084
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1377-2012
  • Fecha de inicio del evento
    2012-01-30
  • Fecha de publicación del evento
    2012-04-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107371
  • 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
    Lipoprotein, low-density, antigen, antiserum, control - Product Code DFC
  • Causa
    In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease.
  • Acción
    Wako Diagnostics notified its customers by telephone on January 26, 2012 and sent an Urgent Medical Device Recall letter dated January 30, 2012 to inform them of the product recall. The notifications identified the affected product, problem and actions to be taken. Consignees were requested to: 1) Complete and sign the attached Return Materials Authorization (RMA) Form to receive replacement material and 2) Package the recalled Product to be returned and send to the address listed on the RMA form. For questions call Technical Support Team at 1-877-714-1924.

Device

Device Recall Wako Autokit Lp(a) Calibrator
  • Modelo / Serial
    Lot No.: DJ427, Exp 08-31-12
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product had been sold to 2 customers in the US.
  • Descripción del producto
    Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo-Ku Osaka 540-8605, Japan***Distributed by: Wako Chemicals USA, Inc. /Wako Diagnostics || 1600 Bellwood Road Richmond, VA 23237*** || Product Usage: The Lp(a) calibrator is intended to be used with the Wako Autokit Lp(a) test to establish the points of reference that are used in the determination of Lp(a) in serum or plasma.
  • Manufacturer
    Wako Chemicals USA, Inc.

Manufacturer

Wako Chemicals USA, Inc.
  • Dirección del fabricante
    Wako Chemicals USA, Inc., 1600 Bellwood Rd, Richmond VA 23237-1326
  • Empresa matriz del fabricante (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA