Alere iScreen Dx Urine Drug Screen Card — Class III medical device recall Z-3084-2017
Terminated recall by Ameditech Inc, reported 2017-09-06, distributed nationwide. The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the k
| Recall number | Z-3084-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ameditech Inc, San Diego, CA, United States |
| Recall initiated | 2017-06-26 |
| Classified | 2017-08-29 |
| Reported by FDA | 2017-09-06 |
| Terminated | 2019-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 263 kits |
| Reason classes | labeling |
| Lot numbers | U0731 |
Product
Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine
Reason for recall
The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.
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-3084-2017. 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.