Ameditech ImmuTest Cup 7-panel Drug Test Recall for Reduced Reactivity
Ameditech is recalling ImmuTest Cup 7-panel drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which the rubric indicates is typically a score of 1 or 2. The hazard involves reduced reactivity for specific compounds, which is a functional defect rather than a direct physical injury risk, fitting the Moderate category for low-risk issues.
Plain-English summary
Ameditech Inc is recalling 60 kits of the ImmuTest Cup 7-panel w/ Adulteration (Item No. IMCA-7P). The affected products were distributed nationwide and include lot codes 143861, 144204, and 144263.
The recall was initiated because the drugs of abuse tests have shown reduced reactivity for up to two of the nineteen benzodiazepine 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
- ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 60
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)
- 143861 144204 144263
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.
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