Ameditech Recalls DrugSmart 10 Test Cups Due to Reduced Reactivity
Ameditech is recalling DrugSmart 10 Test Cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, significant injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Ameditech Inc is recalling the DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D, and the DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D. These products are one-step immunoassays used for the qualitative detection of multiple drugs and drug metabolites in human urine. The recall is being conducted because the tests have shown reduced reactivity.
The recall involves 300 units of the affected products. These items were distributed nationwide in the United States and internationally to Australia. The specific lot codes associated with this recall are 142293, 151047, and 151233.
The DrugSmart 10 Test Cups are intended for professional and point-of-care use. Users should stop using the affected products and contact Ameditech Inc for further instructions or a replacement.
The recalled product
- Product
- DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D 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 these Drugs…
- Manufacturer
- Ameditech Inc
- Hazard
- Affected units
- 300
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)
- 142293 151047 151233
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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