Ameditech recalls Noble 1 Step+ Cup devices due to inconsistent calibrator and compound detection. Products may not detect all substances as labeled. No remedy specified in recall notice.
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 Noble 1 Step+ Cup devices because they fail to consistently detect calibrators and secondary compounds at labeled levels. This means the products might not work as intended for substance testing.
The devices contain immunoassay enzymes that do not work consistently. This causes the products to fail at detecting calibrators and secondary compounds at the levels stated on the label. As a result, the devices may not provide accurate results for substance testing.
Users of the Noble 1 Step+ Cup devices for substance testing are affected. People who rely on these devices for accurate results are most at risk.
Check for the product name 'Noble 1 Step+ Cup' with AMT item numbers like NBCA-13A-B or NBCA-14A-PP. The devices were sold with various calibrator combinations and are all within their expiry dates.
Identify the product by checking the AMT item numbers listed in the recall notice.
The devices contain immunoassay enzymes that fail to consistently detect calibrators and secondary compounds at labeled levels, which may lead to inaccurate results.
The recall notice does not specify a remedy, so no action is required beyond checking if you have the product.
The recall notice does not mention any safety risks, only that the product may not work as intended for substance testing.
We’ve drafted a message you can send Ameditech to request your refund or repair — edit it as you like.
Subject: Recall Z-3039-2020 — Ameditech Ameditech Hello, I own a Ameditech that is covered by recall Z-3039-2020 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.
