Ameditech iCup Dx14 Drug Screen Cup Recalled for Performance Failures
Ameditech is recalling iCup Dx14 Drug Screen Cups because immunoassay enzymes failed performance tests, causing inconsistent detection of compounds.
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, which typically corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Ameditech Inc is recalling the iCup Dx14 Drug Screen Cup, a medical device used for drug detection and adulteration testing. The recall affects 136,925 units distributed nationwide in the United States and in Australia, France, Germany, New Zealand, Singapore, and Spain. All lots within their expiry dates are included in this recall.
The recall was initiated because various immunoassay enzymes in the product failed performance standards. As a result, the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. This performance failure may lead to inaccurate test results.
Users of these products should stop using them and contact Ameditech Inc for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300) 5 Adulteration Tests: Cr, Ni, pH,
- Manufacturer
- Ameditech Inc
- Affected units
- 136,925
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)
- ALL Lots Within Expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 23 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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