OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola
FDA device recall Z-2403-2016 · posted 2016-08-17 · Terminated
Recall details
- Recalling firm
- OraSure Technologies, Inc.
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Quantity affected
- 3,075 units
- Distribution
- Distributed to one customer only in US state of Georgia.
- Date initiated
- 2016-07-20
- Date posted
- 2016-08-17
- Date terminated
- 2017-05-10
- Location
- Bethlehem, PA
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