OraSure recalls specific benzodiazepine test kits due to incorrect lot numbers on calibrators and unit boxes. Affected kits may give inaccurate results. Contact for remedy 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 certain benzodiazepine test kits because the lot numbers on the calibrator and unit boxes are incorrect. This could lead to inaccurate test results, which might affect diagnosis and treatment decisions.
The test kits have incorrect lot numbers listed on both the calibrator and the unit box. This means the kits might not work as intended, potentially giving false negative or positive results for benzodiazepine detection.
Users of the OraSure Benzodiazepine test kits with Product Number 1110IB and Lot Number 6673115 (expiring 03/31/2020) are affected. People using these kits for home drug testing may be at risk of inaccurate results.
Check the product box for Product Number 1110IB and Lot Number 6673115 (expiring 03/31/2020). The kits are labeled as 'Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD'.
Verify the Product Number (1110IB) and Lot Number (6673115) on the kit's box and calibrator.
The product number is 1110IB.
The lot number is 6673115 (expiring 03/31/2020).
No, but you should check the lot number to ensure accuracy. The recall does not require immediate disposal.
We’ve drafted a message you can send OraSure to request your refund or repair — edit it as you like.
Subject: Recall Z-2876-2020 — OraSure OraSure Hello, I own a OraSure that is covered by recall Z-2876-2020 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.
