CLIA Waived recalls certain rapid drug test kits that may not consistently detect drugs due to enzyme failures. Affected products include specific dipstick tests and rapid drug test cups with model numbers X07-CLIA-SDDT-25, X07-CLIA-14-RDTC-A, etc. No remedy is provided in the 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 Inc. is recalling certain CLIA Waived rapid drug test kits because their immunoassay enzymes may fail to consistently detect drugs. This could lead to inaccurate results, meaning users might get false negatives for drugs they are using.
The test kits use immunoassay enzymes that may not work properly, causing them to fail to detect all calibrators and secondary compounds at the levels stated on the label. This means the tests might not identify drugs present in the sample, leading to inaccurate results.
People who purchased CLIA Waived rapid drug test kits with model numbers like X07-CLIA-SDDT-25, X07-CLIA-14-RDTC-A, or similar identifiers from the list. Those most at risk are users who rely on these tests for drug screening and could get false negative results.
Check the product label for model numbers such as X07-CLIA-SDDT-25, X07-CLIA-14-RDTC-A, or similar identifiers listed in the recall notice. The products are CLIA Waived rapid drug tests that include dipstick tests and rapid drug test cups.
Look for model numbers like X07-CLIA-SDDT-25, X07-CLIA-14-RDTC-A, or similar identifiers on the product label.
The recall is because the immunoassay enzymes in these tests may fail to consistently detect all calibrators and secondary compounds at the levels stated in the labeling, leading to inaccurate results.
The recall notice does not specify a remedy, so no action is required beyond checking if your product matches the model numbers listed.
The recall states that the tests may not consistently detect drugs, but there is no mention of physical harm or injury risks. The hazard is related to inaccurate results, not direct health effects.
We’ve drafted a message you can send CLIA Waived to request your refund or repair — edit it as you like.
Subject: Recall Z-3032-2020 — CLIA Waived CLIA Waived Hello, I own a CLIA Waived that is covered by recall Z-3032-2020 from CLIA Waived. 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.
