The Recall Desk
ModerateFDA (Devices)·Z-0528-2016·Announced 2015-12-30

Ameditech ProScreen 6 Panel Dip Card Recall for Reduced Benzodiazepine Reactivity

Ameditech is recalling ProScreen 6 Panel Dip Cards 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 the rubric defines as unlikely to cause adverse health consequences, typically resulting in a score of 1 or 2. The issue involves reduced reactivity for specific compounds rather than a direct safety hazard like injury or death.

Plain-English summary

Ameditech Inc is recalling 168 kits of the ProScreen 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAU. The affected products were distributed nationwide and include lot codes G150001, G150244, and G150293.

The recall was issued 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 with potential reduced reactivity are Clonazepam and Chlordiazepoxide.

Consumers and healthcare providers should stop using the affected test kits and contact Ameditech Inc for further instructions or a replacement.

The recalled product

Product
ProScreen 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAU
Manufacturer
Ameditech Inc
Affected units
168

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)

  • G150001 G150244 G150293

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 →