Z-2403-2016 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 24, 2016
- Initiation Date
- July 20, 2016
- Termination Date
- May 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,075 units
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.
Distribution Pattern
Distributed to one customer only in US state of Georgia.
Code Information
Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.