The Recall Desk
ModerateFDA (Devices)·Z-0537-2016·Announced 2015-12-30

Ameditech ProScreen CLIA Waived Cup Recall for Reduced Benzodiazepine Reactivity

Ameditech is recalling ProScreen CLIA Waived Cup kits because they may show reduced reactivity for two specific 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. 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 129 kits of the ProScreen CLIA Waived Cup with 8 Drug (Item No. PSCup-8P-W). The affected products were distributed nationwide.

The recall is due to reduced reactivity for up to two of the nineteen benzodiazepine compounds listed in the product insert. The specific compounds with potential reduced reactivity are Clonazepam and Chlordiazepoxide.

The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these kits.

The recalled product

Product
ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W
Manufacturer
Ameditech Inc
Affected units
129

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)

  • 142964 150790 151707

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 →