The Recall Desk
ModerateFDA (Devices)·Z-0517-2016·Announced 2015-12-30

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.

What this means for you

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
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.

See all 59 products in this recall →