OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detect...

FDA Device Recall #Z-2403-2016 — Class I — July 20, 2016

Recall Summary

Recall Number Z-2403-2016
Classification Class I — Serious risk
Date Initiated July 20, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm OraSure Technologies, Inc.
Location Bethlehem, PA
Product Type Devices
Quantity 3,075 units

Product Description

OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.

Reason for Recall

Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.

Distribution Pattern

Distributed to one customer only in US state of Georgia.

Lot / Code Information

Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.

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-2877-2020 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.