The Recall Desk
ModerateFDA (Devices)·Z-0309-2016·Announced 2015-11-25

Ameditech Recalls DrugSmart Dip Drug Abuse Tests Due to Reduced Reactivity

Ameditech is recalling 160 units of DrugSmart Dip drug abuse tests because they have shown reduced reactivity. The affected products were distributed in the US and Australia.

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, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving a potential diagnostic error.

Plain-English summary

Ameditech Inc is recalling 160 units of DrugSmart Dip drug abuse tests, specifically Item No. 30600D (MET/OPI2+AMP+BZO+COC+THC) and Item No. 30520D (AMP/OPI2/COC/THC/BZO). These one-step immunoassays are intended for the qualitative detection of multiple drugs and drug metabolites in human urine for professional and point-of-care use.

The recall was initiated because the tests have shown reduced reactivity. The affected products were distributed nationwide in the United States and internationally to Australia.

Consumers and healthcare professionals should stop using the affected DrugSmart Dip tests and contact Ameditech Inc for further instructions or a replacement.

The recalled product

Product
DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of th
Manufacturer
Ameditech Inc
Affected units
160

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)

  • 141379 144260 150225

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 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 20 products in this recall →