Events

Rappel de Device Recall Instrument Manager software

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 Data Innovations, 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
    52105
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0083-2012
  • Date de mise en oeuvre de l'événement
    2009-05-11
  • Date de publication de l'événement
    2011-10-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82110
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Cause
    The "previous result" retrieved from the specimen management database may not be the most recent "previous result".
  • Action
    Data Innovations sent an "IMPORTANT PRODUCT NOTICE" dated May 11, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter offers temporary workarounds for customers to use until corrected versions of the software is complete. Versions of the corrections will be provided on a staggered schedule. Customers will be notified by e-mail. Questions regarding this notice are directed to Support at 802-658-1955.

Device

Device Recall Instrument Manager software
  • Modèle / numéro de série
    S/W Versions 8.05, 8.06, 8.07, 8.08 and 8.09.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) and the country of Canada.
  • Description du dispositif
    Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. || It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
  • Manufacturer
    Data Innovations, Inc.

Manufacturer

Data Innovations, Inc.
  • Adresse du fabricant
    Data Innovations, Inc., 120 Kimball Ave Ste 100, South Burlington VT 05403-6837
  • Source
    USFDA