Ameditech ToxCup Drug Screen Cups Recalled for Performance Failures
Ameditech is recalling ToxCup Drug Screen Cups because they may fail to consistently detect all substances at labeled levels.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 hazard is a performance failure leading to inaccurate test results, which fits the Moderate severity criteria for labeling or performance issues without reported serious injury.
Plain-English summary
Ameditech Inc is recalling 189,175 units of ToxCup Drug Screen Cups. The recall covers various product configurations, including HT29A, DT14, HT15, and others, distributed nationwide in the US and in Australia, France, Germany, New Zealand, Singapore, and Spain.
The recall was initiated because various immunoassay enzymes in the products failed performance testing. As a result, the cups do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. This means the test results may be inaccurate.
The recall includes all lots within their expiry dates. Users of these drug screen cups should stop using the affected products and contact Ameditech Inc for further instructions or a replacement.
The recalled product
- Product
- ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC300/MET500/OPI300/THC50/AMP1000/PCP25/OXY100 Adulteration Screen for CR - NI - PH - BL - S.G.", DT14/ "ToxCup¿ Drug Screen Cup THC50/COC150; OPI300/MET500; AMP500/BZO300…
- Manufacturer
- Ameditech Inc
- Affected units
- 189,175
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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