Henry Schein recalls OneStep+ DOA Cup 14 Panel due to immunoassay enzymes failing to consistently detect all calibrators and compounds as labeled. Affected units may not provide accurate results for drug testing.
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.
Henry Schein is recalling its OneStep+ DOA Cup 14 Panel drug testing kits because the immunoassay enzymes may not consistently detect all substances as labeled. This could lead to inaccurate drug test results if used properly.
The immunoassay enzymes in these kits may fail to consistently detect all calibrator and secondary compounds at the levels specified in the product labeling. This means the test results could be inaccurate, potentially leading to false negatives or positives.
People who own or use Henry Schein OneStep+ DOA Cup 14 Panel drug testing kits for workplace or personal use. Those most at risk are users who rely on these kits for accurate drug screening results.
Check for the Henry Schein OneStep+ DOA Cup 14 Panel with AMT Item Number 570-1066. All lots within expiry date are affected.
Verify if your kit has the AMT Item Number 570-1066 and is within the expiry date.
The immunoassay enzymes may not consistently detect all calibrator and secondary compounds at the levels stated in the labeling, potentially leading to inaccurate test results.
The recall record does not specify a remedy, so check the product details to see if it is affected and contact Henry Schein for further guidance.
The recall indicates potential inaccurate results, not a physical safety hazard. There is no risk of injury from normal use.
We’ve drafted a message you can send Henry Schein to request your refund or repair — edit it as you like.
Subject: Recall Z-3035-2020 — Henry Schein Henry Schein Hello, I own a Henry Schein that is covered by recall Z-3035-2020 from Henry Schein. 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.
