Freestyle Libre 3 Recall: What You Need to Know

FDA Announcement and Recall Details

On October 26, 2022, the US Food and Drug Administration (FDA) announced a recall of the Freestyle Libre 3 glucose monitoring system. The recall affects all lots of Freestyle Libre 3 sensors and readers manufactured between August 1, 2022, and October 19, 2022.

The FDA identified a rare but serious issue with the Freestyle Libre 3 system, which can lead to inaccurate blood glucose readings. Specifically, the sensors may occasionally display incorrect values, either too low or too high, which can be potentially dangerous for people with diabetes.

Affected Devices and Recall Information

Affected Devices:

• Freestyle Libre 3 Sensors (all lots)
• Freestyle Libre 3 Readers (all lots)

Recall Information:

• Recall Number: Z-2236-2022
• Date of Recall: October 26, 2022
• Recall Classification: Class I

Actions for Affected Users

If you are using the Freestyle Libre 3 system, you should immediately:

• Stop using the system.
• Contact your healthcare provider for alternative glucose monitoring options.
• Return the affected sensors and readers to Abbott, the manufacturer.

Symptoms and Risks

The incorrect glucose readings from the Freestyle Libre 3 system can lead to the following symptoms and risks:

• Hypoglycemia (low blood sugar) if the system underestimates glucose levels
• Hyperglycemia (high blood sugar) if the system overestimates glucose levels
• Inappropriate treatment decisions based on inaccurate readings

Abbott's Response

Abbott has issued a recall notice and is actively working to address the issue. The company is providing affected users with replacement sensors and readers. Abbott has also launched an investigation to determine the root cause of the problem.

Future Applications and Opportunities

Despite the recall, the Freestyle Libre 3 system remains a promising technology for continuous glucose monitoring. By leveraging machine learning and data analytics, the system can potentially:

• Improve diabetes management and outcomes
• Reduce hospitalizations and complications
• Facilitate personalized treatment plans
• Empower people with diabetes with real-time data

Impact on Diabetes Management

The recall of the Freestyle Libre 3 system is a setback for diabetes management, but it also highlights the importance of device safety and regulatory oversight. The FDA's actions ensure that patients are protected from potentially harmful products.

Additional Resources

• FDA Recall Notice: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/freestyle-libre-3-system-recall-us
• Abbott Recall Information: https://www.abbott.com/corpnewsroom/freestyle-libre-3-recall.html
• American Diabetes Association: https://www.diabetes.org/

Tables

Table 1: Key Recall Details

Table 2: Symptoms and Risks of Inaccurate Glucose Readings

Table 3: Impact on Diabetes Management

Table 4: Future Opportunities for Continuous Glucose Monitoring Systems