The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Devices)·Z-0538-2016·Announced 2015-12-30

Ameditech ProScreen CLIA Wvd 12 Panel Cup Recall for Reduced Benzodiazepine Reactivity

Ameditech is recalling 1,680 ProScreen CLIA Wvd 12 Panel Cup kits because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 the rubric defines as unlikely to cause adverse health consequences, typically corresponding to a score of 1 or 2. The issue involves reduced reactivity for specific compounds rather than a direct physical hazard.

Plain-English summary

Ameditech Inc is recalling 1,680 units of the ProScreen CLIA Wvd 12 Panel Cup w/Adult. (Item No. PSCupA-12M-W). The affected products were distributed nationwide.

The recall was initiated because the drugs of abuse tests have shown 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 lot codes are 152171, 152216, and 153103.

This recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences. Users should stop using the affected kits and contact the manufacturer for further instructions.

The recalled product

Product
ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W
Manufacturer
Ameditech Inc
Category
Medical Device — Laboratory Test Kit
Hazard
Affected units
1,680

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)

  • 152171 152216 153103

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 →

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