Ameditech Recalls First Check 4 Panel Drug Cups Due to Performance Failures
Ameditech Inc is recalling 537,120 units of First Check 4 Panel Drug Cups because they may fail to consistently detect all compounds at labeled levels.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard involves a risk-of-harm product (medical diagnostic device) where the failure to detect compounds could lead to incorrect medical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ameditech Inc is recalling 537,120 units of First Check 4 Panel Drug Cups (COC/MET1000/OPI2000/THC), AMT Item Number 990100B. 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 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.
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 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 537,120
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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