DrugSmart 10 Test Cup — Class II medical device recall Z-0307-2016
Terminated recall by Ameditech Inc, reported 2015-11-25, distributed nationwide. Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
| Recall number | Z-0307-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ameditech Inc, San Diego, CA, United States |
| Recall initiated | 2015-10-20 |
| Classified | 2015-11-18 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2016-11-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 300 units |
| Model numbers | 61020D, 61055D |
Product
DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D 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 for recall
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0307-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.