Ameditech recalls ToxCup Drug Screen Cups due to inconsistent detection of drugs in tests. Products may fail to detect calibrators and compounds as labeled, risking inaccurate results.
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 ToxCup Drug Screen Cups because the immunoassay enzymes in some models don't consistently detect drugs at the levels stated on the label. This could lead to inaccurate test results, which is important for users relying on these tests for drug screening.
The immunoassay enzymes in these cups can fail to consistently detect calibrator and secondary compounds at the levels specified on the label. This means the test results might not be accurate, potentially leading to false negatives or positives.
People who own or use ToxCup Drug Screen Cups with the specific model numbers listed in the recall (HT29A, HT15, HT15A, PT15, DT13A, DT14A, DT12A, PT12A, PT11A, HT30) are affected. Those using these cups for drug testing are most at risk of inaccurate results.
Check the product label for model numbers like HT29A, HT15, HT15A, PT15, DT13A, DT14A, DT12A, PT12A, PT11A, or HT30. These cups were sold with specific item numbers and may have been manufactured up to the expiry date.
Look for model numbers such as HT29A, HT15, HT15A, PT15, DT13A, DT14A, DT12A, PT12A, PT11A, or HT30 on the cup.
The immunoassay enzymes in these ToxCup Drug Screen Cups may not consistently detect calibrator and secondary compounds at the levels stated on the label, leading to inaccurate test results.
The affected model numbers include HT29A, HT15, HT15A, PT15, DT13A, DT14A, DT12A, PT12A, PT11A, and HT30.
The recall record does not specify a return or remedy, so no action is required beyond checking the product label.
We’ve drafted a message you can send Ameditech to request your refund or repair — edit it as you like.
Subject: Recall Z-3045-2020 — Ameditech Ameditech Hello, I own a Ameditech that is covered by recall Z-3045-2020 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.
