Ameditech Recalls First Check 7 Panel Drug Cups Due to Performance Failures
Ameditech is recalling 99,900 units of First Check 7 Panel Drug Cups because the products failed to consistently detect all compounds at labeled levels.
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. The hazard involves inaccurate test results due to performance failures, which is a moderate risk without reported injuries or deaths.
Plain-English summary
Ameditech Inc is voluntarily recalling 99,900 units of First Check 7 Panel Drug Cups (AMP/COC/MDMA/MET/OPI/PCP/THC), AMT Item Number 990100B. The recall covers all lots within the expiry date. The products were distributed nationwide in the United States and in Australia, France, Germany, New Zealand, Singapore, and Spain.
The recall was initiated because various immunoassay enzymes failed product performance tests. As a result, the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. This defect may lead to inaccurate drug screening results.
Users of these products should stop using them and contact Ameditech Inc for further instructions or a refund. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B
- Manufacturer
- Ameditech Inc
- Hazard
- Affected units
- 99,900
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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