Events

Rappel de Device Recall MEDITECH BiDirectional LAB Analyzer Interface

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 Medical Information Technology, 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
    65158
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1365-2013
  • Date de mise en oeuvre de l'événement
    2013-05-07
  • Date de publication de l'événement
    2013-05-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118048
  • 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
    Medical device data system - Product Code OUG
  • Cause
    Incorrect transmission of laboratory results.
  • Action
    Beginning on May 7, 2013, MEDITECH distributed a notification to MAGIC and Client Server customers who have the MEDITECH Bi-Directional Interactive Communication Analyzer Interface in use with Vitros 3600, 4600, or 5600 Analyzer in TEST and/or LIVE. This notification was made via remailed task updates that can be printed by the customer. Task updates sent via e-mail are immediately transmitted to the customer. This notification informs customers of the potential patient safety issue that could result in reporting inaccurate qualitative results. Customers will receive a corrective change, in which the previous test's results will no longer be associated with the test not performed. Until customers receive the corrective change, they are instructed to monitor all No Result values from their analyzer and confirm that the result in MEDITECH matches. For further questions please call 781-821-3000, ext. 5742.

Device

Device Recall MEDITECH BiDirectional LAB Analyzer Interface
  • Modèle / numéro de série
    Magic Releases 5.41, 5.52. 5.53, 5.62, 5.63, 5.64 and Client Server Releases 5.64, 5.65, 6.05, 6.06, 6.07
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA, including Puerto Rico and the country of Canada.
  • Description du dispositif
    MEDITECH Bi-Directional interactive Communication Analyzer Interface; || Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information.
  • Manufacturer
    Medical Information Technology, Inc.

Manufacturer

Medical Information Technology, Inc.