Events

Retiro De Equipo (Recall) de Urine Specimen Collection Kit

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 Gen-Probe 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
    68229
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1793-2014
  • Fecha de inicio del evento
    2014-04-17
  • Fecha de publicación del evento
    2014-06-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127184
  • 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
    Urine collection kit (excludes hiv testing) - Product Code OIE
  • Causa
    Incorrect labeling was used on each pouch of the affected lots of aptima urine specimen collection kits. the outer box of the kits are identified correctly as "aptima urine collection kits"; however, the inner pouches are incorrectly labeled as "aptima unisex swab collection kit for endocervical and male urethral swab specimens.".
  • Acción
    Hologic sent a Recall Notice letter dated April 14, 2014 via overnight mail (FedEx) to affected customers. The letter identified the affected product, problem and actions to be taken. The notification letter requests customers to: 1. segregate the entire contents of the affected kit lots 2. reconcile and destroy all partial and/or full kits remaining in inventory and to document; the amount destroyed on the Customer Response Form provided with the Recall Notice; 3. if the urine collection kits were further distributed to other collection sites, then to notify them of this issue; and 4. complete and return the Customer Response Form to Technical Support (contact information is provided in the notification letter). For additional information, questions, or concerns, contact Hologic Molecular (Technical) Support. Toll Free: 888-484-4747 Direct: 858-410-8511 Fax: 858-410-8250 Email: molecularsupport@hologic.com

Device

Urine Specimen Collection Kit
  • Modelo / Serial
    Catalog #301040.  Lot Numbers: 27231, 27232, 27233, 27234. Expriation Date: 31JAN2015.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Canada (CA), Denmark (DK), France (FR), Germany (DE), and the United States (US), Belgium (BE), United Kingdom (GB).
  • Descripción del producto
    APTIMA Urine Collection Kit; Catalog Number || 301040, Lots 27231, 27232, 27233, and 27234. || Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.
  • Manufacturer
    Gen-Probe Inc

Manufacturer

Gen-Probe Inc
  • Dirección del fabricante
    Gen-Probe Inc, 10210 Genetic Center Dr, San Diego CA 92121-4362
  • Empresa matriz del fabricante (2017)
    Hologic, Inc.
  • Source
    USFDA