Events

Rappel de Device Recall FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM

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 Abbott Diabetes Care, 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
    52427
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1936-2009
  • Date de mise en oeuvre de l'événement
    2009-06-10
  • Date de publication de l'événement
    2009-09-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82937
  • 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
    System, test, blood glucose, over the counter - Product Code NBW
  • Cause
    Low results: freestyle lite blood glucose test strip may generate low blood glucose readings when tested with the control solution from lot 0822524 with freestyle freedom lite and freestyle lite blood glucose meters.
  • Action
    An "Important: Medical Device Notification" letter dated June 10, 2009 was issued to consignees. First consignees received notifications via letters to both direct consignees and registered customers of FreeStyle Lite and FreeStyle Freedom Lite blood glucose meter users in the states where the affected test strip lot was distributed. Affected accounts and customers were instructed to discontinue distribution and use of the product. The notification will be posted to the Abbott Diabetes Care website. Direct questions about the recall to Abbott Diabetes Care, Inc. by calling 510-749-5400.

Device

Device Recall FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
  • Modèle / numéro de série
    Lot number 0822524, expiration date 2010/08.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US only (states AL, AZ, CA, FL, GA, IL, IN, MD, NJ, NY, OH, PA, RI, SC, TN, TX and WI).
  • Description du dispositif
    FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood Glucose Meters and FreeStyle Freedom Lite Blood Glucose Meters, Part Number 70822-02, manufactured by Abbott Diabetes Care, Inc., Alameda, CA. || The product is used for testing outside the body (in vitro) diagnostic use, in the home and in professional settings to monitor blood glucose levels.
  • Manufacturer
    Abbott Diabetes Care, Inc.

Manufacturer

Abbott Diabetes Care, Inc.
  • Adresse du fabricant
    Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda CA 94502-7000
  • Source
    USFDA