The Recall Desk
ModerateFDA (Devices)·Z-3048-2020·Announced 2020-10-07

Ameditech Recalls First Check 2 Panel Drug Cups Due to Performance Failures

Ameditech is recalling 41,340 units of First Check 2 Panel Drug Cups because the products failed to consistently detect 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, and the hazard involves inaccurate test results without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Ameditech Inc is recalling 41,340 units of the First Check 2 Panel Drug Cup (THC/COC), AMT Item Number 990600B. The recall covers all lots within the expiration 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 means the drug cups may not provide accurate results for the substances they are designed to test for.

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 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B
Manufacturer
Ameditech Inc
Affected units
41,340

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.

See all 23 products in this recall →