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 Blood Glucose Monitors System. For in vitro diagnostic use Recalled by Abbott Diabetes Care, Inc. Due to Abbott Diabetes Care has identified through internal testing...
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 Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China; Distributed by Abbott Diabetes Care, Alameda, CA The FreeStyle mete should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Mete can product inaccurate results. The FreeStyle Glucose meter is incorporated into the OmniPod insulin Management system (manufactured by Insulet Corporation, Bedford, MA and is intended for subcutaneous delivery of insulin. Intended to monitor blood glucose from samples taken from the body. IVD use only,
Quantity: not provided. Device has not been shipped in the last 5 years.
Why Was This Recalled?
Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.
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