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OraSure Technologies, Inc. recalls OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebo
Recalled August 24, 2016 · FDA recall Z-2403-2016 · OraSure Technologies
Hazard
Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions. · FDA Class I
Units
3,075 units
Sold at
Distributed to one customer only in US state of Georgia.
Description
Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.
Product
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
Manufacturer(s)
OraSure Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →