Events

Retiro De Equipo (Recall) de Device Recall Roche 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
    71786
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2447-2015
  • Fecha de inicio del evento
    2015-07-14
  • Fecha de publicación del evento
    2015-08-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139106
  • 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
    Low po2 results. qc failures of the po2 parameter, affecting primarily levels 1 and 2, caused by a calibration issue with the po2 parameter. this issue may not be detected since qc results can be below mean values, but still within 2 standard deviations (sd) limits. potential for erroneously low po2 results in patient samples, especially in blood samples with po2 values below 50 mmhg.
  • Acción
    Roche sent an Urgent Medical Device Correction letter dated July 14, 2015 and the Fax Back form via UPS ground to the customers list. The letter identified the affected product, problem and actions to be taken. Consignees are instructed to discontinue use of affected Fluid Packs and discard them per local guidlines; and complete and return the enclosed faxback form and fax it to 1-888-943-5171 to receive replacement product for Fluid Packs from the affected lot. For questions contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272.

Device

Device Recall Roche cobas b 123 POC system
  • Modelo / Serial
    cobas b 123 Fluid Pack COOx Catalog 05170036001, lot numbers 21446113 (exp 9/5/2015), and 21446153( exp 9/24/2015)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of LA, SC, CA, TX, NE, VA and WV including: Puerto Rico.
  • Descripción del producto
    cobas b 123 Fluid Pack COOX REF 05170036001 400 || Product Usage: || 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, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials.
  • 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