Ameditech ProScProScreen 10 Panel Cup Recall for Reduced Benzodiazepine Reactivity
Ameditech is recalling 96 kits of ProScProScreen 10 Panel Cups due to reduced reactivity for two 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 is defined as unlikely to cause adverse health consequences, aligning with a Moderate severity score for a diagnostic accuracy issue without reported injuries.
Plain-English summary
Ameditech Inc is recalling 96 kits of ProScProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM. The affected products were distributed nationwide.
The recall was initiated because the drugs of abuse tests showed reduced reactivity for up to two of the nineteen benzodiazepine compounds listed in the product insert. The specific compounds with potentially reduced reactivity are Clonazepam and Chlordiazepoxide.
Consumers and healthcare facilities should stop using the affected kits and contact Ameditech Inc for instructions on return or replacement.
The recalled product
- Product
- ProScProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 96
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)
- 144240 150059
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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