Events

Retiro De Equipo (Recall) de Urine Reagent Strips (URS) 10 Parameters

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 Teco Diagnostics.

¿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
    60476
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0512-2012
  • Fecha de inicio del evento
    2011-10-14
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105523
  • 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
    Automated urinalysis system - Product Code KQO
  • Causa
    This recall was initiated in response to findings during a fda inspection of the firm. the firm's recall has been initiated due to improper manufacture of sub-component nitrite paper lot 35134, expiration date: 01/2014. discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets. sampling size submitted for qc testing was insufficient based upon number o.
  • Acción
    Teco Diagnostics sent an "URGENT: MEDICAL DEVICE RECALL" letter dated October 14, 2011 to affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed customers to examine their inventory for the affected product and to quarantine any product found. A Recall Return Response Form was included with the letter for customers to complete and return. Contact the firm's Technical Support Department at (800) 222-9880 for questions regarding this recall.

Device

Urine Reagent Strips (URS) 10 Parameters
  • Modelo / Serial
    Product # 2: URS-II-I00G-00I i. Lot Number: 35224 ii. Expiration Date: 08/2013
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed in CA and Poland.
  • Descripción del producto
    Urine Reagent Strips (URS) 11 Parameters || URS-11-100G-001 || 510(K) number: K970250 || Devise Listing number: D072377 || Each Device consists of 100 strips of Urine Reagent Strips 11 parameters packed with a desiccant pouch inside a black bottle with Cortez Diagnostics Label on the bottle and the bottle placed inside a Cortez Diagnostics Box.
  • Manufacturer
    Teco Diagnostics

Manufacturer

Teco Diagnostics
  • Dirección del fabricante
    Teco Diagnostics, 1268 N Lakeview Ave, Anaheim CA 92807-1831
  • Source
    USFDA