Alere iScreen Dx Urine Drug Screen Card — Class III medical device recall Z-1542-2018
Terminated recall by Ameditech Inc, reported 2018-05-09, distributed in AZ, FL, IL, ND, NV, PA, TN, TX…. The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (
| Recall number | Z-1542-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ameditech Inc, San Diego, CA, United States |
| Recall initiated | 2017-12-15 |
| Classified | 2018-04-28 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2019-02-11 |
| Distributed | AZ, FL, IL, ND, NV, PA, TN, TX, VA |
| Reason classes | labeling |
| Lot numbers | 173351, 173686, 174055, 176002 |
| Model numbers | X11-IS10-DX |
Product
Alere iScreen Dx Urine Drug Screen Card
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1542-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.