CLASS III Device recall · Reported 9 May 2018 · FDA Enforcement Report

Alere iScreen Dx Urine Drug Screen Card recalled by Ameditech

Ameditech is recalling Alere iScreen Dx Urine Drug Screen Card, distributed in 9 states. The recall was initiated on 15 Dec 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesPart No. X11-IS10-Dx, Lot No. 173351, 173686, 174055, 176002.

Quantity recalled828 kits (20,700 devices)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1542-2018
FDA event ID: 79549
Recalling firm: Ameditech, San Diego, CA
Classification: Class III
Status: Terminated
Recall initiated: 15 Dec 2017
FDA classified: 28 Apr 2018
Reported: 9 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

15 Dec 2017	Recall initiated by company
28 Apr 2018	Classified by FDA	+134 days
9 May 2018	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Alere iScreen Dx Urine Drug Screen Card

Where it was distributed

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

Arizona Florida Illinois North Dakota Nevada Pennsylvania Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Part No. X11-IS10-Dx, Lot No. 173351, 173686, 174055, 176002.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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