Device product
First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B
Z-3047-2020
Product summary
- Firm
- Ameditech Inc
- Event
- Event 86335
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47,005 units
- Official record key
device-enforcement:Z-3047-2020
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.