Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Alere iScreen Dx Urine Drug Screen Card Recalled by Ameditech Inc Due to The kit box label incorrectly identifies PCP (instead...

Date: June 26, 2017
Company: Ameditech Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ameditech Inc directly.

Affected Products

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

Quantity: 263Kits

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ameditech Inc

Ameditech Inc has 109 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report