Ameditech iCup DX 10 Panel Drug Test Recall for Reduced Reactivity
Ameditech is recalling iCup DX 10 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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Ameditech Inc is recalling 6,304 kits of the iCup DX 10 Panel w/Adulterant (Item No. I-DXA-1107-142). The affected products were distributed nationwide. The recall involves specific lot codes: 143037, 143106, 144152, 144218, 152456, 152457, 152698, 153048, 153129, 153201, 153385, and 153648.
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 affected are Clonazepam and Chlordiazepoxide. This reduced reactivity may impact the accuracy of test results for these specific substances.
The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Users should check their inventory for the listed lot codes and contact Ameditech Inc for further instructions.
The recalled product
- Product
- iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 6,304
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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