Ameditech iCup DX 12 Panel Drug Test Recall for Reduced Reactivity
Ameditech is recalling iCup DX 12 Panel drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 unlikely to cause adverse health consequences, typically resulting in a score of 1 or 2.
Plain-English summary
Ameditech Inc is recalling 9,566 kits of the iCup DX 12 Panel w/ Adulterant (Item No. I-DXA-1127-023). The recall is due to reduced reactivity for up to two of the nineteen benzodiazepine compounds listed in the product insert. The specific compounds affected are Clonazepam and Chlordiazepoxide.
The affected products were distributed nationwide. The recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences. The issue involves the accuracy of the test results for specific benzodiazepine substances rather than a direct physical hazard to the user.
The recalled product
- Product
- iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 9,566
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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