Ameditech recalls iCup Dx14 Drug Screen Cups due to inconsistent drug detection results. Products may fail to detect calibrators and secondary compounds as labeled.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Ameditech is recalling iCup Dx14 Drug Screen Cups because they may not consistently detect drugs in samples. This could lead to inaccurate test results, which might affect medical decisions.
The cups use immunoassay enzymes that can fail to work properly. This means the cups might not detect all drugs or substances as stated on the label, leading to inconsistent test results.
People who use iCup Dx14 Drug Screen Cups for drug testing are affected. Those with medical conditions requiring accurate drug screening may be at higher risk.
Check for the model number X11-I-DXA-2147-011 or X11-I-DX-1147-022 on the cup. The product was sold with all lots within expiry dates.
Look for the model number X11-I-DXA-2147-011 or X11-I-DX-1147-022 on the cup.
The iCup Dx14 Drug Screen Cups may not consistently detect all drugs and substances as labeled due to failed immunoassay enzymes.
The recall does not specify a remedy, so check the product details and contact Ameditech for further instructions.
The hazard is low risk as the product may not work correctly but does not pose a direct safety risk like injury or fire.
We’ve drafted a message you can send Ameditech to request your refund or repair — edit it as you like.
Subject: Recall Z-3040-2020 — Ameditech Ameditech Hello, I own a Ameditech that is covered by recall Z-3040-2020 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.
