Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
OraQuick Ebola Rapid Antigen Test Recalled by OraSure Technologies, Inc. Due to Failed stability testing at 8 months. This lot...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact OraSure Technologies, Inc. directly.
Affected Products
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
Quantity: 3,075 units
Why Was This Recalled?
Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.
Where Was This Sold?
Distributed to one customer only in US state of Georgia.
About OraSure Technologies, Inc.
OraSure Technologies, Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report