Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-0532-2016·Announced 2015-12-30

Ameditech ProScreen 8 Panel Dip Card Recalled for Reduced Benzodiazepine Reactivity

Ameditech is recalling 82 kits of ProScreen 8 Panel Dip Cards because they may show reduced reactivity for two specific benzodiazepine compounds.

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 is defined as unlikely to cause adverse health consequences. The issue is a performance defect (reduced reactivity) rather than a direct physical hazard, fitting the Moderate severity criteria for minor labeling or performance errors.

Plain-English summary

Ameditech Inc is recalling 82 kits of ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300. The affected products were distributed nationwide.

The recall was initiated because the drugs of abuse tests showed reduced reactivity for up to two of the nineteen benzodiazepine compounds listed in the product insert. The specific compounds with potentially reduced reactivity are Clonazepam and Chlordiazepoxide.

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

The recalled product

Product: ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300
Manufacturer: Ameditech Inc
Category: Medical Device — In Vitro Diagnostics
Hazard: reduced-reactivity
false-negative
Affected units: 82

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)

152950 152951 153325

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 →

Same manufacturer · Ameditech Inc

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Same hazard · reduced reactivity