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.
Other recalls by Ameditech
- ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC300/MET500/OPI300/THC50/AMP1000/PCP25/OXY100 A…
FDA Device · Class II · 2020-10-07 · Ameditech - First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC)
FDA Device · Class II · 2020-10-07 · Ameditech - MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G…
FDA Device · Class II · 2020-10-07 · Ameditech - TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMP300/BZO200/COC300/MET300/OPI300/ THC50 with…
FDA Device · Class II · 2020-10-07 · Ameditech - MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.…
FDA Device · Class II · 2020-10-07 · Ameditech
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.