Orasure Technologies Interept Benzodiazopene Miro-Plate… recallZ-2876-2020 · OraSure Technologies, Inc. · initiated Jul 13, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from OraSure Technologies, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
FDA root cause category: Under Investigation by firm
What the company is doing
OraSure Technologies issued Advisory Letter dated July 17,2020 via email stating reason for letter and action to take: While this kit expired at the end of March, 2020; we wanted to take this opportunity to send an updated Specification Sheet with the lot number of the Oral Fluid Negative Calibrator corrected for your files. If you have any questions regarding this issue please contact ourTechnical Services Department at [email protected] and they can assist you .
Recall details
- Recall number
- Z-2876-2020
- Status
- Terminated
- Initiated by the company
- Jul 13, 2020
- Recalling firm
- OraSure Technologies, Inc.
- Quantity
- 39 kits
- Product code
- JXM
- FDA submissions
- K013882
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.
Product description
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
Code information (models, lots, serial numbers)
Lot Number: 6673115 Exp. Date:03/31/2020 UDI: 608337000238
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Benzodiazepine Intercept 5 Plate Kit 1110IBOrasure Technologies, Inc. · Enzyme Immunoassay, Benzodiazepine1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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