Events

Retiro De Equipo (Recall) de Device Recall VisuaLine Tricyclic Antidepressants

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 Sun Biomedical Laboratories, 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
    48464
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1875-2008
  • Fecha de inicio del evento
    2008-05-28
  • Fecha de publicación del evento
    2008-09-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-06-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71480
  • 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
    Methadone enzyme immunoassay - Product Code DJR
  • Causa
    Product was sold while the devices were under fda 510 (k) review, which was subsequently denied.
  • Acción
    On May 29, 2008, Recall Notification Letters were sent via UPS Ground. Each letter had a red label reading "Market Withdrawal Notification on the envelope. Use of the product and distribution was to stop immediately. Returns to be made by UPS and replacement or refund to be issues. If you have any questions contact Jenny Shelton, Sun Biomedical, at 1-888-440-8388.

Device

Device Recall VisuaLine Tricyclic Antidepressants
  • Modelo / Serial
    Sun Biomedical Part 15-2043; Lot Vis-6SP-Dip 08-021-1; Part 15-2046; lot Vis-6SP-Dip 07-270-1; Part 15-2065, lot Vis-8SP-Dip-07-207-2; Part 15-2072, lot Vis-9SP-Dip-07-106-1; Part 15-2080, lot Vis-10 Dip 06-204-2, Vis-10 Dip 07-002-2, Vis-10-Dip-07-231-1; Part 15-2083, lot Vis-10SP-Dip-07-311-1; Vis-10SP-Dip 07-324-1, VIS 10SP-Dip-08-045-3; Part 15-2085, Lot Vis 10SP Dip-07-201-1, Vis-10SP-Dip 07-263-1; Part 15-2095, lot Vis 5SP-Dip 07-284-2; Vis 5SP-Dip -8-008-01; and Part 15-2101, lot Vis-6SP Dip-07-326-1.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.
  • Descripción del producto
    VisuaLine Tricyclic Antidepressants: || Six Dip (COC-THC-OPI-MET-BZD-OXD); || Six Dip (COC-THC-OPI-MET-PCP-OXD); || Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); || Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA); || Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); || Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); || Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); || Five Dip (COC-THC-OPI-BZD-OXD); and || Six Dip (CPC-THC-OPI-MET-AMP-OXD). || Product is intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
  • Manufacturer
    Sun Biomedical Laboratories, Inc.

Manufacturer

Sun Biomedical Laboratories, Inc.
  • Dirección del fabricante
    Sun Biomedical Laboratories, Inc., 1001 Lower Landing Rd, Blackwood NJ 08012-3124
  • Source
    USFDA