FDA Device recall Z-0304-2016
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 immunoass…
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of 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 immunoass… 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-0304-2016 |
| 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
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
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Identifiers
| code_info | 142320 143666 143753 144217 144414 144439 144454 144510 144952 |
|---|
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-0304-2016%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.