Ameditech ProScreen 8 Panel Dip Card Recalled for Reduced Benzodiazepine Reactivity
Ameditech is recalling ProScreen 8 Panel Dip Cards because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Ameditech Inc is recalling 249 kits of the ProScreen 8 Panel Dip Card, Item No. PSD-8P. The recall is due to 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 products were distributed nationwide. The specific lot codes involved are 152305, 152306, and 153503. This recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected test kits and contact Ameditech Inc for further instructions or a replacement.
The recalled product
- Product
- ProScreen 8 Panel Dip Card, Item No. PSD-8P
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 249
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)
- 152305 152306 153503
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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