The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1267-2014·Announced 2014-04-02

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Category
Medical Device — In Vitro Diagnostic
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

Distributed nationwide across the United States.

The notice also names 9 states specifically:

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 →

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