Events

Rappel de Roche Cobas c111 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
    60146
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0311-2012
  • Date de mise en oeuvre de l'événement
    2011-10-18
  • Date de publication de l'événement
    2011-11-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104528
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    Internal investigations have revealed a potential printer malfunction on the cobas c 111 analyzer, where one or more numbers or characters can be missing on the hard copy result printout, or the printer may skip leaving blanks which may result in an incorrect print layout. the missing number of characters can be in any position, therefore it could be in the middle of a result, (e.G. 48.53 mmol in.
  • Action
    Roche Diagnostics Operations, Inc sent a Urgent Medical Device Correction dated October 18, 2011, via UPS Ground (receipt required) to all affected customers and one distribution center, with instructions to disable the Auto Print Result feature until new software is available. All printed results will need to be confirmed against the results indicated on the display screen. Questions are to be directed to Roche Diagnostics Technical Support at 1-800 428-2336,

Device

Roche Cobas c111 Analyzer
  • Modèle / numéro de série
    Serial Numbers 50865, 50626, 50798, 50731, 50654, 50541, 51023, 50946, 50989, 50634, 50506, 50251, 50887, 50948, 50453, 50688, 51111, 50997, 51122, 50244, 50790, 50475, 50597, 50740, 50656, 50793, 51086, 50999, 51146, 50635, 50744, 50586, 50632, 50846, 1167, 50693, 50787, 50670, 50672, 51128, 50941, 50562, 50788, 50547, 51003, 50624, 50677, 50678, 50814, 51015, 50687, 50680, 50894, 50560, 51004, 50247, 50538, 51118, 50926, 50847, 50841, 51127, 50741, 50764, 50633, 51106, 51116, 50201, 51124, 50612, 51088, 50576, 51016, 50689, 50681, 50424, 51126, 50959, 50878, 50784, 50661, 50761, 50452, 50450, 50290, 50947, 51327, 50630, 50985, 50763, 50319, 50984, 50250, 50549, 50925, 50844, 50660, 50845, 50683, 50735, 51056, 50463, 50775, 50840, 50734, 50655, 50843, 50758, 50852, 50539, 50651, 50653, 50657, 50964, 50563, 50742, 50738, 50727, 50934, 50561, 50803, 51000, 51107, 50686, 50815, 50649, 50470, 50759, 50644, 51053, 50739, 50595, 51087, 50575, and 50679.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including West Virginia and Texas.
  • Description du dispositif
    Roche Cobas c 111 Analyzer || The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA