Events

Rappel de LifeScan

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 Lifescan 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
    31640
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0821-05
  • Date de mise en oeuvre de l'événement
    2005-04-11
  • Date de publication de l'événement
    2005-05-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-01-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38281
  • 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
    User may inadvertently change the units of measure from mg/dl to mmol/l and the blood glucose results could be misinterpreted. this may lead to under treatment and potential for hyperglycemia.
  • Action
    On 4/11/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions on the correction. Owner's booklet: Firm contacted all accounts by letters of 11/21/03, 2/4/2004, 2/17/04 and 2/9-10/2004 providing important information regarding the owner's booklet.

Device

LifeScan
  • Modèle / numéro de série
    ALL CODES: All lot numbers and serial numbers
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution of the product is worldwide. ***Distribution in the United States was between January 15, 2001 for OneTouch Ultra Blood Glucose Meter; April 13, 1998 for OneTouch FastTake Blood Glucose Meter and November 30, 2001 for InDuo Blood Glucose Meter.*** The total number of quantities shipped to consignees is approx. 1.8 Million. Of these, Approx. 282,000 were shipped to Pharmacies and Healthcare Professionals (including Diabetes Educators, Primary Care Physicians, Endocrinologists), Approx. 800 were shipped to Mail Order companies that distribute OneTouch ¿ FastTake¿ and OneTouch ¿ Ultra¿ products, and Approx. 130,000 were shipped to E-mail End User Notifications to LifeScan database of OneTouch¿ Ultra¿, OneTouch¿ FastTake¿ and InDuo¿ product users. Ultra, InDuo, FastTake Meters Global Distribution include: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Caribbean, CEE, Chile, China, Columbia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Latin America, Latin America, Lebanon, Malaysia, Malta, MEA, Mexico, Netherlands, Norway, Oman, Pasean, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia/Gulf Countries, Singapore, Slovakia, Slovenia, South Africa, Spain, Sub-Saharan Africa, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam, and Yemen. Owner's booklet: The recall product was distributed in the U.S. only. LifeScan manufactured and distributed OneTouch Ultra System Kits with the affected OneTouch Ultra Meter Owner's Booklets between March 31, 2003 and October 3, 2003.
  • Description du dispositif
    LifeScan Brand InDuo Blood Glucose Meter
  • Manufacturer
    Lifescan Inc

Manufacturer

Lifescan Inc
  • Adresse du fabricant
    Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035-6301
  • Source
    USFDA