OraQuick Ebola Rapid Antigen Test recall
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
Why was OraQuick Ebola Rapid Antigen Test 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.
- Product
- OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
- Recalling firm
- OraSure Technologies, Inc.
- Quantity
- 3,075 units
- Distribution
- Distributed to one customer only in US state of Georgia.
- Recall date
- August 24, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)