Recall Z-2403-2016— OraSure Technologies, Inc.
Class I · Terminated
Class I FDA medical device recall by OraSure Technologies, Inc., initiated 2016-07-20, terminated 2017-05-10. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- OraSure Technologies, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-07-20
- Terminated
- 2017-05-10
- Firm location
- Bethlehem, PA, United States
Product description
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.