Ameditech Immutest Cup CLIA Waived Recall for Reduced Benzodiazepine Reactivity
Ameditech is recalling Immutest Cup CLIA Waived kits because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
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 is defined as unlikely to cause adverse health consequences. The issue is a performance defect (reduced reactivity) rather than a direct physical hazard like fire or choking.
Plain-English summary
Ameditech Inc is recalling 144 kits of Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W. The affected products were distributed nationwide.
The recall is due to reduced reactivity for up to two of the nineteen Benzodiazepine (BZO) compounds listed in the product insert. Specifically, the tests may show reduced reactivity for Clonazepam and Chlordiazepoxide.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 144
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)
- 143937 144574 145061
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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