Abbott has recalled FreeStyle lnsulinx Blood Glucose Meters in the United States. At extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx Blood Glucose Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. Blood glucose levels at 1024 mg/dL and above are very rare. However, if high blood glucose levels of 1024 mg/dL and above occur, they are a serious health risk that requires immediate medical attention. The FreeStyle InsuLinx Blood Glucose Meter measures sugar (glucose) in blood drawn from the fingertips of people with diabetes to monitor blood sugar levels. On April 15, 2013, Abbott Diabetes Care sent an Urgent Product Recall letter to all its affected customers. The FreeStyle InsuLinx Blood Glucose Meters were distributed from April 18, 2012, through April 1, 2013.
Consumers who are using the FreeStyle InsuLinx Meter should immediately take one of the following actions to address this issue with their meter: Access a software update to install on their meter to resolve the issue at www.freestyleinsulinx.com/swupdate. The software update will allow settings and historical data to be maintained on the meter. Consumers can contact Abbott Diabetes Care Customer Service at 1-866-723-2697 to expedite return and replacement of the FreeStyle InsuLinx meters at no charge. Replacements are available, and Abbott will send a meter immediately upon request. Health care professionals who have FreeStyle InsuLinx Blood Glucose Monitoring Kits were told to immediately discontinue dispensing them to patients.
To arrange for product return and replacement, call Abbott Diabetes Care customer service at 1-866-723-2697. Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online at www.fda.gov/MedWatch/report.htm. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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