Ameditech Recalls Alere iCup Drug Detection Cups Due to Performance Failures
Ameditech Inc is recalling Alere iCup Drug Detection cups because immunoassay enzymes failed performance tests, preventing consistent 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 indicates a temporary or medically reversible adverse health consequence. The source text describes a performance failure leading to inconsistent detection but does not report specific injuries, illnesses, or fatalities, aligning with a Moderate severity rating for a diagnostic device with potential for misdiagnosis.
Plain-English summary
Ameditech Inc is voluntarily recalling specific lots of Alere iCup Drug Detection cups. The recall affects 28,525 units of the product, which are used for drug detection and adulteration screening. The affected items include the iCup Dx 10 Drug Detection + Adulteration, iCup DX Drug Screen Cup 13, and iCup Dx Drugs of Abuse Test. The recall covers all lots within their expiry dates.
The recall was initiated because various immunoassay enzymes in the products failed to meet performance standards. As a result, the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. This means the test results may be inaccurate or unreliable.
The affected products were distributed nationwide in the United States and in Australia, France, Germany, New Zealand, Singapore, and Spain. Users of these products should stop using them and contact Ameditech Inc for further instructions or a replacement.
The recalled product
- Product
- Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup¿ Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup¿ DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 28,525
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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