CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup — Class II medical device recall Z-0304-2016
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-0304-2016 |
|---|---|
| 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 | 7,482 units |
| Model numbers | CLIA-RDTC-12 |
Product
CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12 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
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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.