Device product
First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
Z-3049-2020
Product summary
- Firm
- Ameditech Inc
- Event
- Event 86335
- Status
- Terminated
- Classification
- Class II
- Quantity
- 537,120 units
- Official record key
device-enforcement:Z-3049-2020
Official wording
Reason: 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.
Code information: ALL Lots Within Expiry
Distribution pattern: US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Derived failure modes
-
Unknown
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.