Ameditech ProScreen CLIA Waived Cup Recall for Reduced Benzodiazepine Reactivity
Ameditech is recalling 492 ProScreen CLIA Waived Cup kits due to reduced reactivity for Clonazepam and Chlordiazepoxide.
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 issue involves reduced reactivity for specific compounds, which is a performance defect rather than a direct physical hazard like fire or choking.
Plain-English summary
Ameditech Inc is recalling 492 units of the ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W. The affected products were distributed nationwide. The recall involves specific lot codes: 141779, 142656, 142963, 143874, 144562, and 151996.
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 for which reactivity may be reduced are Clonazepam and Chlordiazepoxide.
Consumers and healthcare providers should check their inventory for the affected item number and lot codes. If the product matches the recalled description, it should be removed from use and returned to the supplier or manufacturer for credit or replacement.
The recalled product
- Product
- ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 492
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)
- 141779 142656 142963 143874 144562 151996
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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