The Recall Desk
ModerateFDA (Devices)·Z-0496-2016·Announced 2015-12-30

Ameditech DrugSmart 9 Test Cup Recalled for Reduced Benzodiazepine Reactivity

Ameditech is recalling DrugSmart 9 Test Cup kits because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

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 III, which is defined as unlikely to cause adverse health consequences, and the issue is a performance defect (reduced reactivity) rather than a direct physical hazard.

Plain-English summary

Ameditech Inc is recalling 320 kits of the DrugSmart 9 Test Cup (BUP), Item No. 60960D. The affected products were distributed nationwide.

The recall was initiated because the drugs of abuse tests have shown reduced reactivity for up to two of the nineteen Benzodiazepine (BZO) compounds listed in the product insert. The specific compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

Consumers and healthcare providers should stop using the affected test kits and contact Ameditech Inc for further instructions.

The recalled product

Product
DrugSmart 9 Test Cup (BUP), Item No. 60960D
Manufacturer
Ameditech Inc
Affected units
320

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 (1)

  • 144029 152738

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 59 recalled by Ameditech Inc 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 59 products in this recall →