Lower riskMedical device recall · FDA · Published July 13, 2020
OraSure Benzodiazepine Test Kit Recall: Incorrect Lot Number Risk
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.
“OraSure Benzodiazepine Test Kit Recall: Incorrect Lot Number Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64729-orasure-benzodiazepine-test-kit-recall-incorrect-lot-number-risk. Based on FDA recall #Z-2877-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2877-2020%22&limit=1).
The FDA announced on July 13, 2020, that OraSure Technologies, Inc. recalled Orasure Technologies Interept Benzodiazepine Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate kits due to an incorrect lot number for the Standard Oral Fluid Negative Calibrator on specification sheets and/or unit boxes.
The recall involves an incorrect lot number for the Standard Oral Fluid Negative Calibrator on the specification sheet included in the kit and/or on the unit box, according to the FDA.
Context
GovInfoNow's records show OraSure Technologies, Inc. has three other recalls on record since December 20, 2017. Other recent recalls of similar products include Broselow Filled Organizer Recall (December 15, 2025), Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), and Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026).
How to tell if you have this one
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.
Brand
OraSure
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.
Look for lot number 6673116 on the calibrator and unit box. This kit expires March 31, 2020.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: District of Columbia, Florida, Maryland, Nevada, New Mexico, New York, Pennsylvania.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2877-2020 (July 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2877-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.