Ameditech Inc recalls Alere iScreen Dx Urine Drug Screen Card

Recall date

December 15, 2017

Source

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

Recall number

Z-1542-2018

FDA classification

Class III

Brand / firm

Ameditech Inc

Sold / distributed

Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.

Why it was recalled

The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.

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

What was recalled

Alere iScreen Dx Urine Drug Screen Card