FDA Device recall Z-0506-2016
iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016
- FDA Device
- Class III
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class III recall of iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016 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-0506-2016 |
| 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 8 Panel w/Adulterant, Item No. I-DXA-187-016
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 | 141971 142195 142397 142674 142997 144209 144463 150018 150883 151525 151526 152180 152741 153045 153150 153151 153211 153376 153650 |
|---|
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-0506-2016%22
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