Retiro De Equipo (Recall) de Device Recall The Roche OMNI S Analyzer: cobas b 221, versions 5 and 6

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Glucose oxidase, glucose - Product Code CGA
  • Causa
    Chemical component of the f3 fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement and 30% at 4.12 mmol/l for lactate. urea readings are unaffected.
  • Acción
    Roche Diagnostics has confirmed an issue with the calibration and QC stability of MSS parameters for cobas b 221 <6> systems. Internal investigations identified the formation of white deposits in the fluidic system, especially in the SD cartridge tubing, as the cause for the premature failure of the MSS parameters. These white deposits can potentially affect the fluidic pathways of both the Standby solution and the calibration solutions Cal1 to Cal4 (from the S3 Fluid Pack) and may reduce the lifetime of metabolite sensor cartridges. The cause of the white deposit has been identified as a chemical component of the S3 Fluid Pack solutions, as well as environmental bacterial contamination. Since this issue involves the S3 Fluid Pack, only the cobas b 221 <6> system is impacted. This issue may have an effect on the calibration of Glucose and Lactate parameters, which may lead to patient results being affected, as calibration drifts may not be detected by calibration and QC procedures. Glucose and Lactate are the only parameters affected by this issue. As a result, Roche is implementing an interim corrective action to be performed on your systems on a regular basis by Roche Field Engineering Specialist (FESs). Read the Urgent Medical Device Correction (UMDC) in its entirety. " Continue to run and maintain your cobas b 221 <6> system as per the Instructions for Use. " Complete the attached fax form and fax it to 1-888-656-6385. " File this UMDC for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272 if you have questions about the information contained in this UMDC. Public Contact is Todd Siesky, at


  • Modelo / Serial
    Model/Catalog/Part #: 1. cobas b221 <6>=Roche OMNI S6 SYSTEM; and 2. 03337154692 - cobas b 221<6>=Roche OMNI S6 SYSTEM CU Potassium - CEM, Calcium - JFP, Sodium - JGS, Chloride - CGZ, Blood Gases (PCO2, PO2) and pH - CHL, Hemoglobin -GKR, Hematocrit - GKF, Oxygen saturation, Carboxyhemoglobin - GHS, Oxyhemoglobin - GGZ, Methemoglobin - KHG, Deoxyhemoglobin - GKA, Lactic Acid - KHP, Glucose- CGA, Urea Nitrogen - CDS.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US Nationwide distribution.
  • Descripción del producto
    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
  • Manufacturer


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