Ameditech Inc: Medical Device Recall in 2018 - (Recall #: Z-1542-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Alere iScreen Dx Urine Drug Screen Card

Product Classification:

Class III

Date Initiated: December 15, 2017

Date Posted: May 9, 2018

Recall Number: Z-1542-2018

Event ID: 79549

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.

Status: Terminated

Product Quantity: 828 kits (20,700 devices)

Code Information:

Part No. X11-IS10-Dx, Lot No. 173351, 173686, 174055, 176002.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated