Alere iCup Drug Detection products may not consistently detect drugs due to enzyme failure. Affected units include specific model numbers and lots within expiry dates. Consumers should contact the manufacturer for details.
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.
Alere iCup Drug Detection products may not consistently detect drugs because of enzyme failures. This means the test results could be inaccurate, potentially leading to incorrect conclusions about drug use.
The products contain immunoassay enzymes that fail to work properly, causing inconsistent detection of drugs. This means the test may not detect all drugs at the levels stated on the label, leading to inaccurate results.
People who own or use Alere iCup Drug Detection products for drug screening are affected. Those using the products for official testing may be at higher risk due to inaccurate results.
Check for model numbers I-DXA-10, I-DXA-13B, or I-DXA-1127-023-N on the product. These units were sold within their expiry dates.
Reach out to Ameditech Inc for specific details about your product and the recall.
The products may not consistently detect drugs due to enzyme failures, leading to inaccurate results.
Models I-DXA-10, I-DXA-13B, and I-DXA-1127-023-N are affected.
No specific stop-use instruction is given; contact the manufacturer for details.
We’ve drafted a message you can send Alere to request your refund or repair — edit it as you like.
Subject: Recall Z-3031-2020 — Alere Alere Hello, I own a Alere that is covered by recall Z-3031-2020 from Alere. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
