Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
UniStrip1 Recalled by Unistrip Technologies LLC Due to Failure to submit a 510(k) for device labeling...
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 Unistrip Technologies LLC directly.
Affected Products
UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Quantity: 7175 units
Why Was This Recalled?
Failure to submit a 510(k) for device labeling changes.
Where Was This Sold?
This product was distributed to 2 states: FL, OH
About Unistrip Technologies LLC
Unistrip Technologies LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report