The Recall Desk
ModerateFDA (Devices)·Z-0518-2016·Announced 2015-12-30

Ameditech ProScreen 10 Panel Dip Card Recalled for Reduced Benzodiazepine Reactivity

Ameditech is recalling ProScreen 10 Panel Dip Cards because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

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, and the issue is a performance defect (reduced reactivity) rather than a direct physical hazard.

Plain-English summary

Ameditech Inc is recalling 2,452 kits of ProScreen 10 Panel Dip Cards (Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300). The recall is due to reduced reactivity for up to two of the nineteen Benzodiazepine (BZO) compounds listed in the product insert. The specific compounds affected are Clonazepam and Chlordiazepoxide.

The affected products were distributed nationwide. The recall includes lots with the following codes: 141963, 142196, 143166, 143475, 143827, 152038, 152172, 152218, 152323, 152393, 152394, 152870, and 153362.

Consumers and healthcare providers should stop using the affected products and contact Ameditech Inc for further instructions.

The recalled product

Product
ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300
Manufacturer
Ameditech Inc
Affected units
2,452

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 →