Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid C...

FDA Device Recall #Z-2877-2020 — Class III — July 13, 2020

Recall Summary

Recall Number Z-2877-2020
Classification Class III — Low risk
Date Initiated July 13, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm OraSure Technologies, Inc.
Location Bethlehem, PA
Product Type Devices
Quantity 13 kits

Product Description

Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT

Reason for Recall

Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.

Lot / Code Information

Lot Number: 6673116 Exp. Date:03/31/2020

Other Recalls from OraSure Technologies, Inc.

Recall # Classification Product Date
Z-1183-2021 Class III Methamphetamine Intercept Microplate kit EIA - ... Feb 5, 2021
Z-3003-2020 Class III Pointts sistema de ellmlnact!;o de verrugas OTC... Jul 15, 2020
Z-3002-2020 Class III Personelle OTC Skin Tag Remover, Canada Catal... Jul 15, 2020
Z-3001-2020 Class III CVS Advanced Wart Remover Kit, Catalog Number: ... Jul 15, 2020
Z-2876-2020 Class III Orasure Technologies Interept Benzodiazopene Mi... Jul 13, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.