Ameditech Alere iScreen Dx Urine Drug Screen Card Recall: Incorrect Drug Labeling
Ameditech recalls Alere iScreen Dx Urine Drug Screen Cards due to incorrect labeling of drug analytes. This could lead to misidentification of Tricyclic Antidepressants as Phencyclidine (PCP) in test results.
Lower-risk 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.
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What happened, in plain English
Ameditech recalls Alere iScreen Dx Urine Drug Screen Cards because the kit box label mistakenly lists Phencyclidine (PCP) instead of Tricyclic Antidepressants (TCAs). This error could cause misidentification of drugs in test results, potentially leading to incorrect conclusions about drug use. Read more at govinfonow.com/recall/72318-ameditech-alere-iscreen-dx-urine-drug-screen-card-recall-incorrect.
Source Summary by GovInfoNow · govinfonow.com/recall/72318-ameditech-alere-iscreen-dx-urine-drug-screen-card-recall-incorrect · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1542-2018
Cite this page
“Ameditech Alere iScreen Dx Urine Drug Screen Card Recall: Incorrect Drug Labeling.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72318-ameditech-alere-iscreen-dx-urine-drug-screen-card-recall-incorrect. Based on FDA recall #Z-1542-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1542-2018%22&limit=1).
Why it’s dangerous
The kit box label incorrectly identifies Phencyclidine (PCP) as one of the drug analytes instead of Tricyclic Antidepressants (TCAs). This labeling error could cause the test to misidentify Tricyclic Antidepressants as PCP, leading to inaccurate results.
Who’s affected
People who own or use Alere iScreen Dx Urine Drug Screen Cards with the specified part and lot numbers are affected. Those testing for drugs and relying on the kit's results may be at risk of misinterpretation.
How to tell if you have this one
Check the product label for part number X11-IS10-Dx and lot numbers 173351, 173686, 174055, or 176002. The Alere iScreen Dx Urine Drug Screen Card is sold by Ameditech Inc.
- Brand
Ameditech- Category
Medical device
What to do — step by step
Check Product Label
Look for part number X11-IS10-Dx and lot numbers 173351, 173686, 174055, or 176002 on the card.
Where it went and when
Where it was distributed
Distributed in 9 states.
FDA distribution: “Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Florida, Illinois, Nevada, North Dakota, Pennsylvania, Tennessee, Texas, Virginia.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1542-2018 (December 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1542-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.