Device product
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
Z-2403-2016
Product summary
- Event
- Event 74843
- Status
- Terminated
- Classification
- Class I
- Quantity
- 3,075 units
- Official record key
device-enforcement:Z-2403-2016
Official wording
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.
Code information: Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.
Distribution pattern: Distributed to one customer only in US state of Georgia.
Derived failure modes
-
Unknown
Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.