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.
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.
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.
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.
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.
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.
Look for part number X11-IS10-Dx and lot numbers 173351, 173686, 174055, or 176002 on the card.
The kit box label incorrectly identifies Phencyclidine (PCP) instead of Tricyclic Antidepressants (TCAs) as one of the drug analytes.
Check the product label for part number X11-IS10-Dx and lot numbers 173351, 173686, 174055, or 176002. If you have these, you may need to contact Ameditech for clarification.
The recall record does not mention a remedy or fix for this labeling error.
We’ve drafted a message you can send Ameditech to request your refund or repair — edit it as you like.
Subject: Recall Z-1542-2018 — Ameditech Ameditech Hello, I own a Ameditech that is covered by recall Z-1542-2018 from Ameditech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
