Ameditech DrugCheck 12 Panel Cup Recalled for Reduced Benzodiazepine Reactivity
Ameditech is recalling 1,907 DrugCheck Waived 12 Panel Cup kits nationwide due to 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 the rubric defines as unlikely to cause adverse health consequences, typically resulting in a score of 1 or 2. The issue is a reduced reactivity for specific compounds rather than a direct physical hazard.
Plain-English summary
Ameditech Inc is recalling 1,907 units of the DrugCheck Waived 12 Panel Cup w/Adult (Item No. DCC-81205-5). The affected products were distributed nationwide.
The recall was initiated because the drugs of abuse tests have shown reduced reactivity for up to two of the nineteen Benzodiazepine (BZO) compounds listed in the product insert. The specific compounds affected are Clonazepam and Chlordiazepoxide.
Consumers and healthcare providers should stop using the affected kits and contact Ameditech Inc for further instructions.
The recalled product
- Product
- DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 1,907
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)
- 143235 144216 151591 153132 153489
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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