Alere iScreen multi-drug detection tests (X11-IS12-DX, X11-IS10BUP-DX, X11-IS10-DX, X11-IS5 M-DX) may not consistently detect drugs due to enzyme failure. Consumers should stop using affected models.
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 iScreen multi-drug detection tests (X11-IS12-DX, X11-IS10BUP-DX, X11-IS10-DX, and X11-IS5 M-DX) have been recalled because their immunoassay enzymes fail to consistently detect drugs. This could lead to inaccurate results, meaning users might not know if drugs are present when they should.
The immunoassay enzymes in these tests can fail to consistently detect all drugs listed on the label. This means the tests might not work properly for some drugs, leading to false negative results where drugs are present but the test shows they are not.
Users of Alere iScreen multi-drug detection tests (X11-IS12-DX, X11-IS10BUP-DX, X11-IS10-DX, and X11-IS5 M-DX) who purchased these tests within their expiry dates. People testing for drug use in themselves or others are most at risk of inaccurate results.
Check the product label for model numbers: X11-IS12-DX, X11-IS10BUP-DX, X11-IS10-DX, or X11-IS5 M-DX. These tests were sold with all lots within their expiry dates.
Immediately stop using any Alere iScreen multi-drug detection tests with model numbers X11-IS12-DX, X11-IS10BUP-DX, X11-IS10-DX, or X11-IS5 M-DX.
The immunoassay enzymes in these tests can fail to consistently detect all drugs listed on the label, leading to inaccurate results.
X11-IS12-DX, X11-IS10BUP-DX, X11-IS10-DX, and X11-IS5 M-DX models.
The recall record does not specify a return process or replacement options.
We’ve drafted a message you can send Alere iScreen to request your refund or repair — edit it as you like.
Subject: Recall Z-3030-2020 — Alere iScreen Alere iScreen Hello, I own a Alere iScreen that is covered by recall Z-3030-2020 from Alere iScreen. 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.
