The Recall Desk
ModerateFDA (Devices)·Z-0535-2016·Announced 2015-12-30

Ameditech ProScreen Drug Test Kits Recalled for Reduced Benzodiazepine Detection

Ameditech is recalling ProScreen CLIA Waived Cup 6 Drugs kits 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. The issue is a reduced reactivity for specific compounds rather than a complete failure or contamination, fitting the criteria for a moderate severity score.

Plain-English summary

Ameditech Inc is recalling 2,136 units of ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W. 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 kits with the following codes: 141906, 143153, 143803, 150003, 150207, 150650, 151786, and 152081.

Consumers and healthcare providers should check their inventory for the specific item number and codes listed above. If the product matches the description, it should be returned to the distributor or manufacturer for credit.

The recalled product

Product
ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W
Manufacturer
Ameditech Inc
Affected units
2,136

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)

  • 141906 143153 143803 150003 150207 150650 151786 152081

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 →