OraSure recalls certain Benzodiazepine test kits due to incorrect lot numbers on calibrators and unit boxes. This may lead to inaccurate results. Check your kit's lot number and contact OraSure for details.
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
OraSure is recalling specific benzodiazepine test kits because the lot numbers on the calibrators and unit boxes are incorrect. This could cause inaccurate test results, which might affect diagnosis and treatment decisions.
The test kits have incorrect lot numbers listed on the calibrator and unit box. This error could lead to inaccurate test results, potentially causing incorrect conclusions about benzodiazepine use.
Users of the OraSure Benzodiazepine test kits with lot number 6673116 (expiring March 31, 2020) are affected. People using these kits for drug testing may be at risk of inaccurate results.
Check the lot number on the calibrator and unit box. The affected kits have lot number 6673116, expiring March 31, 2020. The product is an IVD (in vitro diagnostic) test kit for benzodiazepines.
Look for lot number 6673116 on the calibrator and unit box. This kit expires March 31, 2020.
No, this recall is for inaccurate test results, not a physical hazard. The risk is low because the error doesn't cause injury.
Check the lot number on the calibrator and unit box. Affected kits have lot number 6673116, expiring March 31, 2020.
Contact OraSure directly for instructions on how to handle the kit. The recall does not require immediate action beyond checking the lot number.
We’ve drafted a message you can send OraSure to request your refund or repair — edit it as you like.
Subject: Recall Z-2877-2020 — OraSure OraSure Hello, I own a OraSure that is covered by recall Z-2877-2020 from OraSure. 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.
