First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B
Reported: October 7, 2020 Initiated: August 18, 2020 #Z-3048-2020
Product Description
First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B
Reason for Recall
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Details
- Recalling Firm
- Ameditech Inc
- Units Affected
- 41,340 units
- Distribution
- US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B. Recalled by Ameditech Inc. Units affected: 41,340 units.
Why was this product recalled? ▼
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 7, 2020. Severity: Moderate. Recall number: Z-3048-2020.
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