Ameditech ProScreen 10 Drug Panel Cassette Test Recalled for Reduced Reactivity
Ameditech is recalling ProScreen 10 Drug Panel Cassette Tests because they may show reduced reactivity for specific benzodiazepine compounds.
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 defined as unlikely to cause adverse health consequences. The hazard involves reduced reactivity for specific compounds, which is a functional defect rather than a direct physical injury risk.
Plain-English summary
Ameditech Inc is recalling 160 kits of the ProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPX. The affected products were distributed nationwide and are identified by lot codes 152164 and 153134.
The recall was initiated because the tests have shown reduced reactivity for up to two of the nineteen benzodiazepine compounds listed in the product insert. The specific compounds affected are Clonazepam and Chlordiazepoxide. This issue may impact the accuracy of test results for these specific substances.
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 10 Drug Panel Cassette Test, Item No. PSP-10PPX
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 160
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)
- 152164 153134
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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