OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
Reported: August 24, 2016 Initiated: July 20, 2016 #Z-2403-2016
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.
Details
- Recalling Firm
- OraSure Technologies, Inc.
- Units Affected
- 3,075 units
- Distribution
- Distributed to one customer only in US state of Georgia.
- Location
- Bethlehem, PA
Frequently Asked Questions
What product was recalled? ▼
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.. Recalled by OraSure Technologies, Inc.. Units affected: 3,075 units.
Why was this product recalled? ▼
Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 24, 2016. Severity: Critical. Recall number: Z-2403-2016.
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