AMS Uric Acid Test Kits Recalled for Regulatory Violations
AMS Diagnostics is recalling 13 Uric Acid test kits because they were marketed outside FDA 510(k) requirements.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies a regulatory violation (marketing outside 510(k) requirements) without reporting specific injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
AMS Diagnostics, LLC is recalling 13 kits of AMS URIC ACID, a device used for the in vitro quantitative determination of Uric Acid in serum. The recall was initiated because the devices were marketed outside of FDA 510(k) requirements.
The affected products include Model Numbers 40147 and 80147 with Lot codes 131253, 131254, and 131255. The kits were distributed nationwide, including in Florida, Georgia, Maryland, California, North Carolina, Massachusetts, South Carolina, Wyoming, and Texas.
Consumers and healthcare facilities should stop using the affected kits and contact AMS Diagnostics for further instructions.
The recalled product
- Product
- AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.
- Manufacturer
- AMS Diagnostics, LLC
- Hazard
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model Numbers: 40147
- 80147. Lot codes: 131253
- 131254
- 131255.
Distribution
Part of a larger recall action
This product is one of 3 recalled by AMS Diagnostics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · AMS Diagnostics, LLC
See all →- LowAMS Diagnostics Recalls Medica ISE Module Calibrant A Due to Physical Defects
FDA (Devices) · 2017-07-19
- ModerateAMS AST Diagnostic Kits Recalled for Marketing Outside 510(k) Requirements
FDA (Devices) · 2014-04-02
- ModerateAMS BUN Urea Nitrogen Kits Recalled for Marketing Violations
FDA (Devices) · 2014-04-02
Same hazard · regulatory violation
See all →- ModerateOne Step P in vitro diagnostic test lacks FDA premarket clearance
FDA (Devices) · 2026-05-13
- ModerateOne Step K in vitro diagnostic test recall for missing FDA clearance
FDA (Devices) · 2026-05-13
- ModerateOne Step pH In Vitro Diagnostic Test Recalled Without FDA Clearance
FDA (Devices) · 2026-05-13
- HighCucumber mint lemonade distributed unpasteurized in violation of juice HACCP rules
FDA (Food) · 2025-08-20
- HighGreen Reviver juice distributed unpasteurized in violation of juice HACCP rules
FDA (Food) · 2025-08-20