Ameditech Inc recalls Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1…

Recall date

June 26, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3084-2017

FDA classification

Class III

Brand / firm

Ameditech Inc

Sold / distributed

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

Why it was 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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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