Events

Retiro De Equipo (Recall) de Cobas b 123 POC 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
    75709
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1077-2017
  • Fecha de inicio del evento
    2015-09-03
  • Fecha de publicación del evento
    2017-01-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151082
  • 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
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Causa
    Under specific settings, an issue may occur during simultaneous sensor cartridge and fluid pack change on the cobas b 123 <2> poc system and cobas b 123 <4> poc system. the issue occurs when the software function [autoqc as follow-up] is configured to run all three levels of autoqc only after a fluid pack change, but not after a sensor cartridge change. when both are changed simultaneously, starting with the sensor cartridge and followed by the fluid pack, the analyzer carries out only the follow-up actions associated with the sensor cartridge change after completing the change workflow. as a result, no follow-up autoqc is performed and the three expected autoqc measurements for the fluid pack change are not carried out. without running quality control, there is a remote possibility that system issues would not be detected and wrong results would not be excluded on all parameters: ph, po2, pco2, na+, k+, ca++, cl-, glu, lac, hct, so2, o2hb, cohb, methb, hhb, and bili.
  • Acción
    Roche issued an Analyzer Bulletin on September 3, 2015, to all affected Consignees. The recall notifications included a description of the reason for the recall, affected product, and consignee responsibilities; the notification did not include instructions for responding to the notification. Actions Required " Follow the workaround outlined in this Analyzer Bulletin to avoid the described issue. " File this Analyzer Bulletin for future reference. Questions Please contact the Roche Support Network Customer Support Center at 1-800-526-2272 if you have questions about the information contained in this Analyzer Bulletin.

Device

Cobas b 123 POC system
  • Modelo / Serial
    Models: cobas b 123 <2> POC system: 05122252001 cobas b 123 < 4 > POC system: 05122287001 Serial numbers: 11074  2274  2550  2302  2304  2309  1253  2420  2337  2147  2389  2418  2425  1749  2462  2338  2339  1850  2328  2500  1374  2301  1349  2400  2344  2350  1860  1941  2006  2128
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, LA, NE, PR, SC, TX, VA, and WV
  • Descripción del producto
    Cobas b 123 POC system || The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COT~b, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

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