Ameditech Recalls First Check 1 Panel Drug Cup Due to Performance Failures
Ameditech Inc is recalling First Check 1 Panel Drug Cup (THC) units because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device failing to perform as labeled, which poses a risk of harm through inaccurate diagnostic results, though no specific injuries are reported in the source text.
Plain-English summary
Ameditech Inc is recalling 2,555,630 units of the First Check 1 Panel Drug Cup: (THC), AMT Item Number 990400B. The recall covers all lots within expiry and includes products distributed nationwide in the United States as well as in Australia, France, Germany, New Zealand, Singapore, and Spain.
The recall was initiated because various immunoassay enzymes in the product failed performance standards. As a result, the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. This is classified as an FDA Class II recall.
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 1 Panel Drug Cup: (THC); AMT Item Number 990400B
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 2,555,630
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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