The Recall Desk
ModerateFDA (Devices)·Z-0521-2016·Announced 2015-12-30

Ameditech ProScreen 12 Panel Cup Recall for Reduced Benzodiazepine Reactivity

Ameditech is recalling ProScreen 12 Panel Cups 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 typically a score of 1 or 2. It is scored as 2 because it involves a diagnostic performance issue (reduced reactivity) rather than a cosmetic or documentation-only defect.

Plain-English summary

Ameditech Inc is recalling 1,200 kits of the ProScreen 12 Panel Cup w/Adult. (Item No. PSCupA-12M). The affected products were distributed nationwide.

The recall is due to reduced reactivity for up to two of the nineteen Benzodiazepine (BZO) compounds listed in the product insert. Specifically, the tests may show reduced reactivity for Clonazepam and Chlordiazepoxide.

The source text does not specify instructions for consumers or healthcare providers regarding the disposal or replacement of these kits.

The recalled product

Product
ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M
Manufacturer
Ameditech Inc
Affected units
1,200

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)

  • 142570 144104

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 →