Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Recalled by Abbott Diabetes Care, Inc. Due to AT rare, extremely high glucose levels (1024 mg/dL...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Diabetes Care, Inc. directly.
Affected Products
FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
Quantity: 335,273 meters; 209,336 remain at firm.
Why Was This Recalled?
AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott Diabetes Care, Inc.
Abbott Diabetes Care, Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report