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FDA Recall – FreeStyle Libre 3 and Libre 3 Plus Sensors

The FDA has issued a Class I recall for specific lot numbers of FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring sensors due to the potential for inaccurately low glucose readings.

This recall does NOT affect:

Patients may start asking about this recall. Please see the FDA notification below, which includes a link to the full list of affected lot numbers.

Recommended patient counseling points:

  • Always confirm surprisingly low (or symptomatic) sensor readings with a fingerstick blood glucose test.
  • Patients should immediately check any sensors they have at home against the affected lot list.
  • If they have affected sensors, they can request free replacement sensors directly from Abbott using the online process (link and instructions below).
  • Until unaffected sensors are received, patients without spare unaffected sensors should monitor glucose exclusively with fingerstick testing.

Early Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care | FDA 

 

Sara Jones, Pharm D.

Consulting Pharmacist

Northwest Human Services

503-480-1626

The 340B Drug Pricing Program is managed by the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA). For more information visit: www.hrsa.gov/opa This material is provided for general informational purposes of 340B Drug Prices only and is not an endorsement of any prescription product referenced herein. For information as to the clinical use or efficacy of a referenced product, please contact the manufacturer. 340B Price Guide makes no representations and provides no warranties as to the effectiveness or suitability for use of any prescription product referenced herein. Any referenced cost is provided as an estimate only and the actual cost is subject to change at any time and without notice. 340B Price Guide does not guarantee that the cost represented herein will be the actual and pharmacy shall at all times collect amounts due as indicated at the time of adjudication and shall be reimbursed per the terms of its agreement.'