OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
FDA Recall Z-2403-2016 · Posted 2016-08-17
Recalling FirmOraSure Technologies, Inc.
Recall StatusTerminated
Date Initiated2016-07-20
Date Terminated2017-05-10
Product Quantity3,075 units
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.
Firm Action
OraSure contacted the sole customer via email and mail (letter dated July 21, 2016) to request return of all the product from the affected lot.
Root Cause
Process control
Distribution Pattern
Distributed to one customer only in US state of Georgia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.