FDA Device recall Z-0504-2016
iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
- FDA Device
- Class III
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class III recall of iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023 by Ameditech, citing ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0504-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-11-16 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ameditech |
| Distribution | US |
Product
iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
Reason
Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.
Identifiers
| code_info | 143345 143442 151537 152163 152334 152674 152697 153075 153127 153216 153390 153499 153634 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Ameditech
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FDA Device · Class II · 2020-10-07 · Ameditech - First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC)
FDA Device · Class II · 2020-10-07 · Ameditech - MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G…
FDA Device · Class II · 2020-10-07 · Ameditech - TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMP300/BZO200/COC300/MET300/OPI300/ THC50 with…
FDA Device · Class II · 2020-10-07 · Ameditech - MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.…
FDA Device · Class II · 2020-10-07 · Ameditech
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0504-2016%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.