FDA recall Z-1542-2018

Product

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-12-15

Report date

2018-05-09

Termination date

2019-02-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1542-2018