The Recall Desk
ModerateFDA (Devices)·Z-0520-2016·Announced 2015-12-30

Ameditech ProScreen 12 Drug Cup Recall for Reduced Benzodiazepine Reactivity

Ameditech is recalling ProScreen 12 Drug Cups 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 indicates the product is not likely to cause adverse health consequences. The issue is a performance defect (reduced reactivity) rather than a direct physical hazard like injury or death.

Plain-English summary

Ameditech Inc is recalling 636 kits of the ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU. 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 compounds listed in the product insert. The specific compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units.

The recalled product

Product
ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU
Manufacturer
Ameditech Inc
Affected units
636

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)

  • 142986 143352 151745 152170 153262

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 →