The Recall Desk
ModerateFDA (Devices)·Z-1269-2014·Announced 2014-04-02

AMS AST Diagnostic Kits Recalled for Marketing Outside 510(k) Requirements

AMS Diagnostics is recalling 116 AMS AST kits because they were marketed outside FDA 510(k) requirements. The recall covers nationwide distribution.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any illnesses or injuries, and the hazard is regulatory (marketing outside 510(k) requirements) rather than a direct physical defect causing harm.

Plain-English summary

AMS Diagnostics, LLC is recalling 116 kits of AMS AST, a device used for the in vitro quantitative determination of AST 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 80146. Specific lot codes involved in the recall are 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.

This recall is classified as Class II by the FDA. Consumers and healthcare facilities should stop using the affected kits and contact AMS Diagnostics for further instructions.

The recalled product

Product
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
Manufacturer
AMS Diagnostics, LLC
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
116

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
  • 80146. 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 →

Related recalls

Same manufacturer · AMS Diagnostics, LLC

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Same hazard · regulatory non compliance

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