Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AMS URIC ACID For the In vitro quantitative determination of Recalled by AMS Diagnostics, LLC Due to Marketing the devices outside 510(k) requirements
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 AMS Diagnostics, LLC directly.
Affected Products
AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.
Quantity: 13 kits
Why Was This Recalled?
Marketing the devices outside 510(k) requirements
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About AMS Diagnostics, LLC
AMS Diagnostics, LLC has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report