Events

Retiro De Equipo (Recall) de Calcium test system

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 Roche Diagnostics Operations, 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
    57455
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1823-2011
  • Fecha de inicio del evento
    2010-10-11
  • Fecha de publicación del evento
    2011-03-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96430
  • 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
    Cresolphthalein complexone, calcium - Product Code CIC
  • Causa
    The firm has recieved complaints of imprecision and erroneous patient results for calcium on the cobas integra and cobas c 501 system using reagent lots 62601901 and 63020401.
  • Acción
    The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated October 11, 2010 to all consignees/customers via UPS(signature required) . The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the recalled product; discard from inventory according to their site's local regulations; complete and return the attached Faxback form via fax to 1-877-598-5705 even if they do not have the affected product, and file this letter for future reference. The firm added lot 63020401 to the recall in 3/2011. The firm is mailing an URGENT MEDICAL DEVICE REMOVAL notice to customers that purchased that lot of product. Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have questions about the information contained in this letter.

Device

Calcium test system
  • Modelo / Serial
    Lots 62601901 and 63020401.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311, 501 and 502, Part number 20763128322, Roche Diagnostics Corporation, Indianapolis, IN. || For the in vitro quantitative determination of calcium in serum, plasma and urine.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Dirección del fabricante
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    USFDA