Ameditech Inc: Medical Device Recall in 2017 - (Recall #: Z-3084-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: June 26, 2017

Date Posted: September 6, 2017

Recall Number: Z-3084-2017

Event ID: 77702

Reason for Recall:

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.

Status: Terminated

Product Quantity: 263Kits

Code Information:

P/N IS10-DX; Lot No. U0731

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated