Events

Rappel de Device Recall Enzyme Immunoassay, Vancomycin

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
    74312
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2304-2016
  • Date de mise en oeuvre de l'événement
    2016-05-26
  • Date de publication de l'événement
    2016-08-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147131
  • 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
    Radioimmunoassay, vancomycin - Product Code LEH
  • Cause
    Roche diagnostics operations, inc. has issued a voluntary recall for the online tdm vancomycin assay on the cobas c 311/501/502 analyzers and the modular analytics p module due method sheets that state an incorrect method comparison against the cobas integra 800 analyzer.
  • Action
    Roche sent an Urgent Medical Device Correction letter dated May 26, 2016, to all affected customers via UPS Ground (receipt required) . The letter identified the product the problem and the action needed to be taken by the customer. Customers will be informed to disregard the method comparison data in the package insert and to follow the instructions outlined in UMDC 16-083. Non-responding accounts will be defined as users for which confirmation of receipt of the Urgent Medical Device Correction cannot be obtained. These accounts will be monitored on an ongoing basis and follow-up attempts will be made accordingly. Affected product under Roche control was placed on hold. Affected product will be reworked to add a sticker referring to customers to UMDC 16-083. Roche is not requesting return of the affected product. Any returned product will be managed according to current procedures. The incorrect method comparison will be removed from the method sheets. Updated method sheets will be released at a later time. Customers may contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336.

Device

Device Recall Enzyme Immunoassay, Vancomycin
  • Modèle / numéro de série
    04491050190  ONLINE TDM Vancomycin 100 tests 05108420190  ONLINE TDM Vancomycin 200 tests 04642490190  Hitachi Vancomycin (Modular P) 04642481190  Hitachi Vancomycin (917, MOD P)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN,TX, UT, VA, VT, WA, WI, WV, WY Foreign:None VA/DOD: See list below
  • Description du dispositif
    ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) || The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers.
  • 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