FDA Device recall Z-0308-2016
DrugSmart 11 Test Cup, Item No. 61127D
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of DrugSmart 11 Test Cup, Item No. 61127D 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-0308-2016 |
| 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
DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10, Item No. 61093D-3C 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 | 140770 142294 151050 151527 142527 140998 142526 150596 151122 151196 |
|---|
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-0308-2016%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.