OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
This recall has been terminated (originally issued August 17, 2016).
- Company
- Orasure Technologies, Inc.
- Recall Initiated
- July 20, 2016
- Posted
- August 17, 2016
- Terminated
- May 10, 2017
- Recall Number
- Z-2403-2016
- Quantity
- 3,075 units
- Firm Location
- Bethlehem, PA
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed to one customer only in US state of Georgia.
Lot / Code Info
Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.
Root 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.
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