FDA Device recall Z-1542-2018
Alere iScreen Dx Urine Drug Screen Card
- FDA Device
- Class III
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class III recall of Alere iScreen Dx Urine Drug Screen Card by Ameditech, citing the kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1542-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-12-15 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ameditech |
| Distribution | AZ, FL, IL, ND, NV, PA, TN, TX, VA |
Product
Alere iScreen Dx Urine Drug Screen Card
Reason
The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.
Identifiers
| code_info | Part No. X11-IS10-Dx, Lot No. 173351, 173686, 174055, 176002. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1542-2018%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.