Events

Retiro De Equipo (Recall) de Device Recall ToxCup Drug Screen Cup

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 Branan Medical Corporation.

¿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
    67818
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1508-2014
  • Fecha de inicio del evento
    2014-03-26
  • Fecha de publicación del evento
    2014-04-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-07-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126393
  • 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
    Enzyme immunoassay, cocaine and cocaine metabolites - Product Code DIO
  • Causa
    May be labeled with incorrect result interpretation graphics on the toxcup lid label.
  • Acción
    The firm, Branan Medical Corp (BMC), sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 26, 2014 to all the customers who received the ToxCup Drug Screen Cup. The letter describes the product, problems identified and the actions to be taken. Customers are instructed to discontinue use and/or sale of product; quarantine all units of these product lots; destroy unused product(s) in compliance with your laboratory and state requirements; share this information with your staff and retain notification as part of your QS documentation; if distributed to your customers, provide a copy of this letter to them; complete and return the enclosed Customer Verification Form via Fax to: Branan Medical Corporation at 949-598-7167 or by e-mail at: branan.complaints@brananmedical.com within 10 days. Should you have any questions about the information contained in this notification, contact Branan Medical Corporation at (949) 598-7166 or email branan.complaints@brananmedical.com.

Device

Device Recall ToxCup Drug Screen Cup
  • Modelo / Serial
    Lot Numbers: O0056 O0067 N0854 O0013 O0099 O0100 O0057 O0059 O0060 O0079
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and country of Canada.
  • Descripción del producto
    ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only.
  • Manufacturer
    Branan Medical Corporation

Manufacturer

Branan Medical Corporation
  • Dirección del fabricante
    Branan Medical Corporation, 140 Technology Dr Ste 400, Irvine CA 92618-2426
  • Empresa matriz del fabricante (2017)
    Branan Medical Corporation
  • Source
    USFDA