Ameditech Recalls 12-Panel Dip Drug Screens Due to Reduced Reactivity
Ameditech is recalling 12-Panel Dip Drug Screens with adulterant because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect of 'reduced reactivity' in a diagnostic test implies a risk of inaccurate results rather than direct physical injury, fitting the Moderate severity criteria for a medical device without reported harm.
Plain-English summary
Ameditech Inc is recalling 12-Panel Dip Drug Screens with adulterant, Item No. PSDA-12BUP. These are one-step immunoassays used for the qualitative detection of multiple drugs and drug metabolites in human urine, intended for professional and point-of-care use. The recall is being conducted because the tests have shown reduced reactivity.
The affected products were distributed worldwide, including nationwide in the United States and internationally to Australia. The recall involves 960 units. Specific lot codes associated with the recall include 144302, 150323, 150661, 151143, and 151467.
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any specific adverse health events or injuries resulting from the use of these tests.
The recalled product
- Product
- 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP 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 of Abuse Tests consist of a combination of dr
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 960
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)
- 144302 150323 150661 151143 151467
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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