Events

Rappel de Device Recall The Roche OMNI S Analyzer: cobas b 221, versions 5 and 6

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
    70023
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1041-2015
  • Date de mise en oeuvre de l'événement
    2014-12-18
  • Date de publication de l'événement
    2015-02-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132123
  • 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
    Glucose oxidase, glucose - Product Code CGA
  • Cause
    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.
  • Action
    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 todd.siesky@roche.com.

Device

Device Recall The Roche OMNI S Analyzer: cobas b 221, versions 5 and 6
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide distribution.
  • Description du dispositif
    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
  • 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