FDA Recall
Terminated
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
Recall: Z-2403-2016
·
Initiated July 20, 2016
Recall
- Recall Number
- Z-2403-2016
- Event Number
- 74843
- Firm
- OraSure Technologies, Inc.
- FEI Number
- 2528909
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- July 20, 2016
- Posted
- August 17, 2016
- Terminated
- May 10, 2017
- Address
- 1745 Eaton Ave, Bethlehem, PA, 18018-1769
Description
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
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.
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.
Distribution
Distributed to one customer only in US state of Georgia.
Quantity
3,075 units