FDA Device recall Z-0300-2016
11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of 11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K by Ameditech, citing ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0300-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-20 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ameditech |
| Distribution | US |
Product
11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
Reason
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Identifiers
| code_info | 150503 144376 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0300-2016%22
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