The Recall Desk
ModerateFDA (Devices)·Z-0526-2016·Announced 2015-12-30

Ameditech ProScreen 6 Panel Cup Recall for Reduced Benzodiazepine Reactivity

Ameditech is recalling ProScreen 6 Panel 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 FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a performance issue (reduced reactivity) rather than a direct physical injury risk, fitting the Moderate category for minor labeling or performance errors.

Plain-English summary

Ameditech Inc is recalling 7,805 kits of the ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU. The recall is due to reduced reactivity for up to two of the nineteen benzodiazepine compounds listed in the product insert. The specific compounds affected are Clonazepam and Chlordiazepoxide.

The affected products were distributed nationwide. The recall covers specific lot codes including G140258, G140313, G140314, G140368, G140384, G140389, G140399, G140426, G150185, G150199, G150246, and G150307.

Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the affected kits. The FDA has classified this as a Class III recall, indicating that use of the product is not likely to cause adverse health consequences.

The recalled product

Product
ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU
Manufacturer
Ameditech Inc
Affected units
7,805

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 →