RecallRadar

FDA Device recall Z-3084-2017

Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert

On 2017-09-06 the FDA classified a Class III recall of Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert by Ameditech, citing 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 labele….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-3084-2017
ClassificationClass III
Statusterminated
Initiated2017-06-26
Published2017-09-06
Last updated2026-09-13 11:54 UTC
CompanyAmeditech
DistributionUS

Product

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

Reason

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.

Identifiers

code_infoP/N IS10-DX; Lot No. U0731

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Other recalls by Ameditech

All Ameditech recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3084-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.