Events

Rappel de Cobas b 123 POC system

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Roche Diagnostics Operations, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75709
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1077-2017
  • Date de mise en oeuvre de l'événement
    2015-09-03
  • Date de publication de l'événement
    2017-01-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151082
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including CA, LA, NE, PR, SC, TX, VA, and WV
  • Description du dispositif
    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.
  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA