FDA-Device2016-08-24Class I
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
OraSure Technologies, Inc.
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.
Sold states
Distributed to one customer only in US state of Georgia.
Affected count
3,075 units
Manufactured in
1745 Eaton Ave, N/A, Bethlehem, PA, United States
Products
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2403-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief