Recall Z-2403-2016
OraSure Technologies, Inc. · initiated July 20, 2016
Class I – dangerous or defective products that could cause serious health problems or death
Product
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
Codes / lots: Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2403-2016
- Initiated
- July 20, 2016
- Posted by FDA
- August 17, 2016
- Terminated
- May 10, 2017
- Quantity
- 3,075 units
- Distribution
- Distributed to one customer only in US state of Georgia.
- Recalling firm
- OraSure Technologies, Inc., Bethlehem, PA