OraSure Technologies, Inc.
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
| Date | Aug 17, 2016 (initiated Jul 20, 2016) |
| Status | Terminated |
| Reason | Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions. |
| Root cause | Process control |
| 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. |
| Quantity | 3,075 units |
| Distribution | Distributed to one customer only in US state of Georgia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.