The Recall Desk
ModerateFDA (Devices)·Z-0508-2016·Announced 2015-12-30

Ameditech Immutest 11 Pnl Drug Screen Cup Recall for Reduced Reactivity

Ameditech is recalling Immutest 11 Pnl Drug Screen 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 is typically a score of 1 or 2. The hazard involves reduced reactivity in a diagnostic test, which is a functional defect rather than a direct physical injury risk, fitting the Moderate category for minor labeling or functional errors.

Plain-English summary

Ameditech Inc is recalling 240 kits of the Immutest 11 Pnl Drug Screen Cup w/ Adult (Item No. IMCA-11OP). The product was distributed nationwide.

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 source text does not specify instructions for consumers or the number of affected units beyond the 240 kits mentioned in the structured data.

The recalled product

Product
Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP
Manufacturer
Ameditech Inc
Affected units
240

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)

  • 144103

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 →