Ameditech Recalls DrugSmart Drug Abuse Test Cups Due to Reduced Reactivity
Ameditech is recalling specific DrugSmart drug abuse test cups because they have shown reduced reactivity. The affected units 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. The hazard is reduced reactivity, which is a functional defect that may lead to inaccurate results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ameditech is recalling the DrugSmart 11 Test Cup, DrugSmart 12 Test Cup (Multi & BUP), DrugSmart 9 Test Cup (BUP), and DrugSmart Cup 10. These products are one-step immunoassays used for the qualitative detection of multiple drugs and drug metabolites in human urine. They are intended for professional and point-of-care use.
The recall is being conducted because the tests have shown reduced reactivity. A total of 1,220 units are affected. The products were distributed nationwide in the United States and internationally to Australia.
Consumers and healthcare professionals should stop using these specific test cups and contact Ameditech for further instructions or a replacement.
The recalled product
- Product
- DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10, Item No. 61093D-3C These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple dru
- Manufacturer
- Ameditech Inc
- Hazard
- Affected units
- 1,220
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)
- 140770 142294 151050 151527 142527 140998 142526 150596 151122 151196
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.
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