FDA Device recall Z-3049-2020
First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC)
- FDA Device
- Class II
- terminated
- Published 2020-10-07
On 2020-10-07 the FDA classified a Class II recall of First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC) by Ameditech, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3049-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-18 |
| Published | 2020-10-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ameditech |
| Distribution | US |
Product
First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
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.
Identifiers
| code_info | ALL Lots Within Expiry |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3049-2020%22
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