Ameditech Recalls First Check 14 Panel Drug Cups Due to Performance Failures
Ameditech is recalling 47,005 units of First Check 14 Panel Drug 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 corresponds to a moderate severity score. The hazard involves inaccurate test results rather than direct physical injury or death, and no illnesses or injuries are reported in the source text.
Plain-English summary
Ameditech Inc is recalling 47,005 units of the First Check 14 Panel Drug Cup (BMC style), AMT Item Number 990700B. The recall covers all lots within expiry. The product was distributed nationwide in the United States and in Australia, France, Germany, New Zealand, Singapore, and Spain.
The recall was initiated because various immunoassay enzymes in the product failed performance requirements. 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 testing results.
Consumers and healthcare providers should stop using the affected drug cups and contact Ameditech Inc for further instructions or a replacement.
The recalled product
- Product
- First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B
- Manufacturer
- Ameditech Inc
- Hazard
- Affected units
- 47,005
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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