Ameditech ProScreen 6 Panel Dip Card Recall for Reduced Benzodiazepine Reactivity
Ameditech is recalling ProScreen 6 Panel Dip Cards because they may show reduced reactivity for two specific benzodiazepine compounds.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the Low severity criteria for documentation or minor performance issues.
Plain-English summary
Ameditech Inc is recalling 2,675 kits of ProScreen 6 Panel Dip Cards, including Item Nos. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, and PSD-6MB. 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 compounds listed in the product insert. The specific compounds for which there may be 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 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB,
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 2,675
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.
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