Reported May 9, 2018 · Terminated

Alere iScreen Dx Urine Drug Screen Card

Ameditech Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ameditech Inc · 9940 Mesa Rim Rd · San Diego, CA · 92121-2910

Is this the product you have?

  • Alere iScreen Dx Urine Drug Screen Card
Lot codes and dates
    • Part No. X11-IS10-Dx
    • Lot No. 173351
    • 173686
    • 174055
    • 176002
Amount recalled
828 kits (20,700 devices)

Where it was sold

Why it was 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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Ameditech Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 11, 2019 · Data as of Sep 19, 6:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.