Events

Retiro De Equipo (Recall) de Device Recall Alere iScreen Dx Urine Drug Screen Card

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 Ameditech 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
    77702
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-3084-2017
  • Fecha de inicio del evento
    2017-06-26
  • Estado del evento
    Completed
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157665
  • 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
    U.V. Spectrometry, tricyclic antidepressant drugs - Product Code LFH
  • Causa
    The kit box label incorrectly identifies pcp (instead of tca) as one of the 10 drug analytes included in the kit. the pouch label, product insert, and the device itself are labeled correctly.
  • Acción
    Ameditech, Inc. sent an Medical Device Labeling Correction letter to all affected consignees. Remaining product at the firm was quarantined and will be scrapped. Consignees will be notified of the labeling error with a correction notification. The kit label has been corrected and is available for future product. The firm plans to conduct effectiveness checks based upon receipt of the Label Correction notification by consignees. Firm indicates that no customer action is required, so no formal reply from distributors is necessary. Customers who have not had confirmed receipt of correction notification will be telephoned. For questions regarding this recall call 858-805-3607.

Device

Device Recall Alere iScreen Dx Urine Drug Screen Card
  • Modelo / Serial
    P/N IS10-DX; Lot No. U0731
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
  • Descripción del producto
    Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. || The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine
  • Manufacturer
    Ameditech Inc

Manufacturer

Ameditech Inc
  • Dirección del fabricante
    Ameditech Inc, 9940 Mesa Rim Rd, San Diego CA 92121-2910
  • Source
    USFDA