FDA Device recall Z-0301-2016
11 Panel Dip Card (OPI 2000), Item No. 11125AA2K
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of 11 Panel Dip Card (OPI 2000), Item No. 11125AA2K 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-0301-2016 |
| 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 Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA 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 | 142898 151145 142899 |
|---|
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-0301-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.