Ameditech Recalls iCup Drug Screen Cups Due to Reduced Reactivity
Ameditech is recalling iCup drug screen cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.
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 II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a functional defect (reduced reactivity) rather than a direct physical or biological threat, fitting the criteria for a moderate severity rating.
Plain-English summary
Ameditech Inc is recalling specific iCup Drug Screen Cup and iCup DX Drug Screen products because they have shown reduced reactivity. The recall includes multiple item numbers, such as I-DXA-187-016, I-DXA-167-013, I-DXA-1107-142, I-DXA-1117-131, and I-DXA-1127-023. These are one-step immunoassays intended for the qualitative detection of multiple drugs and drug metabolites in human urine for professional and point-of-care use.
The affected products were distributed nationwide in the United States and internationally to Australia. The total quantity involved in the recall is 27,638 units. The source text does not specify the exact dates of distribution or the specific facilities where the products were sold.
Consumers and healthcare professionals should stop using the affected iCup drug screen cups and contact Ameditech Inc for further instructions or a replacement. The reduced reactivity may affect the accuracy of the test results.
The recalled product
- Product
- iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-16
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 27,638
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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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