AMS BUN Urea Nitrogen Kits Recalled for Marketing Violations
AMS Diagnostics is recalling 167 BUN Urea Nitrogen 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, but the source text cites a regulatory marketing violation rather than a direct physical hazard or reported illness, aligning with the rubric for moderate severity.
Plain-English summary
AMS Diagnostics, LLC is recalling 167 kits of AMS BUN UREA NITROGEN, a device used for the in vitro quantitative determination of Urea Nitrogen in serum. The recall was initiated because the devices were marketed outside of FDA 510(k) requirements.
The affected products include model numbers 40072, 40146, and 81046. The recall covers specific lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, and 141081. The products were distributed nationwide, including in Florida, Georgia, Maryland, California, North Carolina, Massachusetts, South Carolina, Wyoming, and Texas.
No specific health hazards or injuries are reported in the source text. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
- Manufacturer
- AMS Diagnostics, LLC
- Hazard
- Affected units
- 167
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 (16)
- Model Numbers: 40072
- 40146
- 81046. Lot codes: 131083
- 131084
- 131085
- 131086
- 131087
- 131088
- 131089
- 1310810
- 1310811
- 1310812
- 1310813
- 1310814
- 1310815
- 141081.
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.
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