Events

Retiro De Equipo (Recall) de Device Recall Teco Diagnostics Uritek TC101 Urine Analyzer

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
    57157
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0577-2011
  • Fecha de inicio del evento
    2010-10-01
  • Fecha de publicación del evento
    2010-12-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95485
  • 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 has been initiated due to the clia-101 urine analyzer not having 510(k) clearance by the fda for use in measuring urinary glucose or occult blood with the clia waived, inc. clia-10 test strips. teco diagnostics has been notified by the fda that the clia-101 requires 510(k) clearance and is not clia waived for use with the clia-10 test strips. without fda approval or clearance, teco di.
  • Acción
    Teco Diagnostics initiated an "Urgent: Medical Device Recall" letter dated October 14, 2010, with an attached "Recall Return Response Form" to the affected consignees via US Postal on October 15, 2010. The recall notice informed the consignees of the reason for recall, the products affected and the actions required. Consignees were instructed to complete and return the enclosed Recall Return Response Form as soon as possible via mail, fax, or email. Upon receipt of the Recall Return Response Form, Teco Diagnostics would work with the consignees/distributors to process any refunds or reimbursements for the returned product and return shipping. If consignees/distributor had questions, they were to call Teco's Technical Support Department at (800) 222-9880 or (714) 463-1111.

Device

Device Recall Teco Diagnostics Uritek TC101 Urine Analyzer
  • Modelo / Serial
    All units sold (2005 - 2010)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, AND WV and the country of Canada.
  • Descripción del producto
    NDC, Inc. Pro Advantage Urine Analyzer, Catalog Number: Pro Advantage Urine Analyzer || The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.
  • Manufacturer
    Teco Diagnostics

Manufacturer

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