Z-3084-2017Class III

Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched...

Name: Z-3084-2017 Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched...
Creator: Ameditech Inc
Published: 2017-06-26
License: https://open.fda.gov/license/

Ameditech, Inc. / initiated 2017-06-26 / Terminated / root cause: labeling and UDI

FDA source

Ameditech Inc began a recall of 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... on 2017-06-26. FDA classified it as Class III and gives the reason as "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". 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-3084-2017
Classification: Class III
Status: Terminated
Initiated: 2017-06-26
Posted: 2017-08-29
Terminated: 2019-08-06
Recalling firm: Ameditech, Inc.
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
Product code: LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Ameditech, Inc. sent an Medical Device Labeling Correction letter to all affected consignees. Remaining product at the firm was quarantined and will be scrapped. Consignees will be notified of the labeling error with a correction notification. The kit label has been corrected and is available for future product. The firm plans to conduct effectiveness checks based upon receipt of the Label Correction notification by consignees. Firm indicates that no customer action is required, so no formal reply from distributors is necessary. Customers who have not had confirmed receipt of correction notification will be telephoned. For questions regarding this recall call 858-805-3607.
Quantity in commerce: 263Kits
Distribution: Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
Product codes and lots: P/N IS10-DX; Lot No. U0731

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3084-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3084-2017	Class III	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-29

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)