The Recall Desk
ModerateFDA (Devices)·Z-0493-2016·Announced 2015-12-30

Ameditech DrugSmart 10 Test Cup Recall for Reduced Benzodiazepine Reactivity

Ameditech is recalling 340 DrugSmart 10 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 the rubric defines as unlikely to cause adverse health consequences, typically resulting in a score of 1 or 2. The hazard involves reduced reactivity for specific compounds rather than a direct physical injury risk.

Plain-English summary

Ameditech Inc is recalling 340 units of the DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D. The affected products were distributed nationwide and include lots 143978, 144485, 151982, and 153095.

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 affected are Clonazepam and Chlordiazepoxide.

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

The recalled product

Product
DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D
Manufacturer
Ameditech Inc
Affected units
340

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)

  • 143978 144485 151982 153095

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 →