Ameditech ProScreen 12 Panel Dip Card Recalled for Reduced Benzodiazepine Reactivity
Ameditech is recalling ProScreen 12 Panel Dip Cards 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, and the issue is a specific reactivity defect rather than a direct physical hazard.
Plain-English summary
Ameditech Inc is recalling 60 kits of ProScreen 12 Panel Dip Cards, Item No. PSD-12BUP. 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 for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.
Consumers and healthcare providers should stop using the affected products and contact Ameditech Inc for further instructions.
The recalled product
- Product
- ProScreen 12 Panel Dip Card, Item No. PSD-12BUP
- 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)
- 152401
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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