Events

Rappel de Device Recall FreeStyle Lite Blood Glucose Test Strips

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
    66886
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0486-2014
  • Date de mise en oeuvre de l'événement
    2013-11-18
  • Date de publication de l'événement
    2013-12-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123985
  • 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
    Certain lots of freestyle and freestyle lite blood glucose test strips produce erroneously low blood glucose results when using freestyle blood glucose meters, freestyle flash blood glucose meters and the freestyle blood glucose meter built into the omnipod system. erroneously low results that are not recognized may pose significant risks to your health.
  • Action
    Abbott Diabetes Care sent an Urgent Product Recall letter in November 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers who were affected were instructed to take the following steps: Call Abbott Diabetes Care Customers Service immediately at 1-888-736-9869 for replacement of the affected product. While waiting for replacement strips to arrive, use an alternate method to measure their blood glucose. If only test strips available to customers were from affected lots, customers should not stop testing their blood glucose. Customers were instructed to dispose of the test strips in accordance with their local and state disposal regulations. Customers with questions were instructed to call Abbott Diabetes Care Customers Service at 1-888-736-9869. For questions regarding this recall call 510-239-2775. Abbott issued a press release at the request of CDRH on november 27, 2013.

Device

Device Recall FreeStyle Lite Blood Glucose Test Strips
  • Modèle / numéro de série
    Part number: 71026-70;  Lot number: 1281732; Exp. date: 2014/05; Lot number: 1283603; Exp. date: 2014/06;  Part number: 70827-71: Lot number: 1363015, Exp. Date: 2014/11; Lot number: 1363109, Exp. Date 2014/11:  Lot number: 1365921, Exp. Date 2014/12;  Part number 70827-72: Lot number: 1366006 Exp. Date : 2014/12; Lot number 1366111, Exp. Date: 2014/12; Lot number 1366337; Exp. Date: 2014/12; Lot number: 1366515, Exp Date: 2014/12;  Part number 70822-71; Lot number 1283345: Exp. Date: 2014/05; Lot number 1365920; Exp. Date: 2014/12; Lot number 1365934; Exp. Date: 2014/12;  Part number: 70822-72: Lot number: 1350414: Exp Date: 2014/07; Lot number 1363321; Exp. Date 2014/11:  Part number: 70819-70: Lot Number: 1365056: Exp. Date 2014/11; Lot number: 1366347: Exp. Date: 2014/12; Lot number: 1367917; Exp. Date 2014/12 Lot number: 1374907; Exp. Date 2015/03.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark, Egypt, Finland, France, Germany, Jamaica, Ireland, Israel, United Kingdom, Luxembourg, Netherlands, Norway, Sweden, Switzerland, UAE, and Canada. **Center Recommended Depth - Consumers/User**
  • Description du dispositif
    FreeStyle Lite Blood Glucose Test Strips; || For in vitro diagnostic testing. || 50 count; 100 count Product of Ireland; || UPC 6 99073 70819 9; - 50 count || UPC 6 99073 70822 9 - 50 count || UPC 6 99073 71026 0 - 50 count || UPC 6 99073 70827 4 - 100 count || Manufactured by Abbott Diabetes Care Inc. Alameda, CA. || The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
  • Manufacturer
    Abbott Diabetes Care, Inc.

Manufacturer

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