FDA-Device2020-10-07Class II
First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B
Ameditech Inc
Hazard
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.
Sold states
US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Affected count
2,555,630 units
Manufactured in
9940 Mesa Rim Rd, N/A, San Diego, CA, United States
Products
First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3046-2020Don't want to check this manually?
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