Events

Recall of Device Recall Abbott brand FreeStyle Navigator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Diabetes Care, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50202
  • Event Risk Class
    Class 2
  • Event Number
    Z-1196-2009
  • Event Initiated Date
    2008-11-01
  • Event Date Posted
    2009-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74980
  • Notes / Alerts
    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.
  • Extra notes in the data
    Sensor, glucose, invasive - Product Code MDS
  • Reason
    The product has the units of measure set to mmol/l rather than mg/dl. the blood glucose results could be misinterpreted. this may lead to under treatment and potential for hyperglycemia.
  • Action
    The Consignees of the affected FreeStyle Navigator Receiver Kit was contacted via telephone, Federal Express or an Abbott representative beginning on November 1, 2008. Contact Customer Service at 1-866-597-5520 with further questions.

Device

Device Recall Abbott brand FreeStyle Navigator
  • Model / Serial
    Lot Number: 01M2278; Serial Numbers: BAAH223-80915 and BAAH223-80182.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    US Distribution to states of NY and AZ.
  • Product Description
    Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number: 70789-01. || The product is manufactured by Benchmark Electronics, 3535 Technology Drive NW, Rochester, MN and distributed by Abbott Diabetes Care, 1360 South Loop Road, Alameda, CA.
  • Manufacturer
    Abbott Diabetes Care, Inc.

Manufacturer

Abbott Diabetes Care, Inc.
  • Manufacturer Address
    Abbott Diabetes Care, Inc., 1360 S Loop Rd, Alameda CA 94502-7000
  • Source
    USFDA