Ameditech iCup DX 8 Panel Drug Tests Recalled for Reduced Benzodiazepine Reactivity
Ameditech is recalling iCup DX 8 Panel drug tests 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 agency classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a performance defect (reduced reactivity) rather than a direct physical hazard.
Plain-English summary
Ameditech Inc is recalling 8,290 units of the iCup DX 8 Panel w/Adulterant (Item No. I-DXA-187-016). The affected products were distributed nationwide.
The recall was issued 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 with potential reduced reactivity are Clonazepam and Chlordiazepoxide.
The source text does not specify instructions for consumers or healthcare providers regarding the disposal or replacement of these units.
The recalled product
- Product
- iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 8,290
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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