FDA Device recall Z-0509-2016
Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W
- FDA Device
- Class III
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class III recall of Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W 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-0509-2016 |
| 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
Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W
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 | 141758 141921 142657 143178 143581 144563 151337 152240 152782 153154 153401 |
|---|
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-0509-2016%22
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