FDA Device recall Z-0516-2016
ProScreen 10 Panel Cup, Item No. PSCup-10M
- FDA Device
- Class III
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class III recall of ProScreen 10 Panel Cup, Item No. PSCup-10M 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-0516-2016 |
| 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 10 Panel Cup, Item No. PSCup-10M
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 | 142596 142984 142985 143144 143145 143146 143240 143241 143351 143875 144102 144106 144239 144241 150651…142596 142984 142985 143144 143145 143146 143240 143241 143351 143875 144102 144106 144239 144241 150651 151706 152165 152167 152168 153102 153107 153251 153411 153412 153633 |
|---|
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-0516-2016%22
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