Ameditech Recalls Consult Diagnostics Drugs Abuse Test Cups
Ameditech Inc is recalling 31,600 units of Consult Diagnostics Drugs Abuse Test Cups because immunoassay enzymes failed performance tests, leading to 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a performance defect leading to inconsistent detection, which fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ameditech Inc is voluntarily recalling 31,600 units of Consult Diagnostics Drugs Abuse Test Cups. The affected product is the 14-Drug Panel with Adulterants, identified by AMT Item Number 164-DXA14. The recall covers all lots within their expiry dates.
The recall was initiated because various immunoassay enzymes in the product failed performance requirements. As a result, the test cups do not consistently detect all calibrator and secondary compounds at the levels stated in the product labeling. This defect may lead to inaccurate test results.
The affected units were distributed nationwide in the United States and in Australia, France, Germany, New Zealand, Singapore, and Spain. Users of these test cups should stop using them and contact Ameditech Inc for further instructions or a refund.
The recalled product
- Product
- Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult Diagnostics DRUGS OF ABUSE TEST CUP 14-DRUG PANEL WITH ADULTERANTS AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",
- Manufacturer
- Ameditech Inc
- Affected units
- 31,600
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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