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FDAJune 26, 2017device

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 ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

ameditech

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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