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 PCP instead of TCA in the kit. This may cause misidentification of drugs in urine tests.
Lower-risk 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.
Contact the company
What happened, in plain English
Ameditech recalls Alere iScreen Dx Urine Drug Screen Cards because the kit box incorrectly lists PCP (a drug) instead of TCA. This could lead to misidentifying drugs in urine tests. The pouch labels and product inserts are correct. Read more at govinfonow.com/recall/73571-ameditech-alere-iscreen-dx-urine-drug-screen-card-recall-incorrect.
Source Summary by GovInfoNow · govinfonow.com/recall/73571-ameditech-alere-iscreen-dx-urine-drug-screen-card-recall-incorrect · Updated September 21, 2026 · FDA enforcement record: FDA #Z-3084-2017
Cite this page
“Ameditech Alere iScreen Dx Urine Drug Screen Card Recall: Incorrect Drug Labeling.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73571-ameditech-alere-iscreen-dx-urine-drug-screen-card-recall-incorrect. Based on FDA recall #Z-3084-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3084-2017%22&limit=1).
Why it’s dangerous
The kit box label incorrectly identifies PCP instead of TCA as one of the 10 drug analytes. This could cause the test to misidentify drugs in urine samples. The pouch labels, product inserts, and the device itself are correctly labeled.
Who’s affected
People who purchased the Alere iScreen Dx Urine Drug Screen Cards for home drug testing. Those using the kit for medical purposes may be at risk of misidentifying drugs due to the labeling error.
How to tell if you have this one
Check for the Alere iScreen Dx Urine Drug Screen Card with 20 Drug Detection. The kit includes 26 individually pouched devices and 1 IFU insert. The product was sold with the part number IS10-DX and lot number U0731.
- Brand
Ameditech- Category
Medical device
What to do — step by step
Check Label Accuracy
Verify the kit box label for correct drug analytes; the pouch labels and product inserts are accurate.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
FDA distribution: “Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Illinois, Indiana, Kentucky, Nevada, Pennsylvania, Tennessee, Texas.
Recall timeline
FDA terminated this recall 2.1 years 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-3084-2017 (June 26, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3084-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 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.