Z-1542-2018Class III

Alere iScreen Dx Urine Drug Screen Card

Name: Z-1542-2018 Alere iScreen Dx Urine Drug Screen Card
Creator: Ameditech Inc
Published: 2017-12-15
License: https://open.fda.gov/license/

Ameditech, Inc. / initiated 2017-12-15 / Terminated / root cause: labeling and UDI

FDA source

Ameditech Inc began a recall of Alere iScreen Dx Urine Drug Screen Card on 2017-12-15. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1542-2018
Classification: Class III
Status: Terminated
Initiated: 2017-12-15
Posted: 2018-04-28
Terminated: 2019-02-11
Recalling firm: Ameditech, Inc.
Product: Alere iScreen Dx Urine Drug Screen Card
Product code: LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Customers were notified on about 12/15/2017. Instructions included to become aware of the recall so as to relay the information to customers with questions.
Quantity in commerce: 828 kits (20,700 devices)
Distribution: Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
Product codes and lots: Part No. X11-IS10-Dx, Lot No. 173351, 173686, 174055, 176002.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1542-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1542-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-28

Product code LFH

K022355Class IIQuicktox Multiple Drug Dipcard Coc/met/thc/amp/pcp/bzo/bar/mtd/tca, Model Qt61Branan Medical Corp. / cleared 2002-07-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)