# FDA recall Z-3084-2017

> **Ameditech Inc** · Class III · device recall initiated 2017-06-26.

## 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.

## Distribution

Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX

## Key facts

- **Recall number:** Z-3084-2017
- **Recalling firm:** Ameditech Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-26
- **Report date:** 2017-09-06
- **Termination date:** 2019-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3084-2017

## Citation

> AI Analytics. FDA recall Z-3084-2017. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-3084-2017. Source: US FDA. Licensed CC0.

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