FDA Device recall Z-0527-2016
ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB
- FDA Device
- Class III
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class III recall of ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB 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-0527-2016 |
| 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
ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB,
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 | 141955 142043 142055 142161 142513 142600 142824 142937 142938 142969 143143 143149 143234 143513 143758…141955 142043 142055 142161 142513 142600 142824 142937 142938 142969 143143 143149 143234 143513 143758 143806 143807 144441 152035 152042 152075 152911 153237 153240 153523 |
|---|
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-0527-2016%22
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