Alere iScreen Dx Urine Drug Screen Card
FDA Recall #Z-1542-2018 — Class III — December 15, 2017
Product Description
Alere iScreen Dx Urine Drug Screen Card
Reason for Recall
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.
Recalling Firm
Ameditech Inc — San Diego, CA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
828 kits (20,700 devices)
Distribution
Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
Code Information
Part No. X11-IS10-Dx, Lot No. 173351, 173686, 174055, 176002.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated