Events

Rappel de Device Recall Omni Microelectrode for cobas b221 analyzer

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
    67549
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1315-2014
  • Date de mise en oeuvre de l'événement
    2014-02-28
  • Date de publication de l'événement
    2014-04-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125702
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notes supplémentaires dans les données
  • Cause
    Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous ph and/or sodium results. other ion parameters are not affected.
  • Action
    Roche Diagnostics Operations sent an Urgent Medical Device Correction letter dated February 27, 2014 via UPS Ground (receipt required) to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the enclosed fax form and fax it to 1-888-345-0253. For questions contact Roche Customer Business Support Center at 1-800-428-5076.

Device

Device Recall Omni Microelectrode for cobas b221 analyzer
  • Modèle / numéro de série
    all serial numbers
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribution
    Worldwide Distribution - USA nationwide including PR and the country of Guam.
  • Description du dispositif
    Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: || 03111873180 as a part of the following systems: || 1. 03337103001, cobas b 221<1>Roche OMNI S1 system || 2. 03337111001, cobas b 221<2>Roche OMNI S2 system || 3. 03337154001,cobas b 221<6>Roche OMNI S6 system || 4. 03337138001, cobas b 221<4>Roche OMNI S4 system || Product Usage: Usage: || Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxycarboxy and methemoglobin
  • 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