FDA Medical Device Recalls (openFDA)
OraSure Technologies, Inc.: OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
- Recall number
- Z-2403-2016
- Recalling firm
- OraSure Technologies, Inc.
- Product
- OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
- Status
- Terminated
- Initiated
- 2016-07-20
- Posted
- 2016-08-17
- Terminated
- 2017-05-10
- 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.
- Root cause
- Process control
- Action
- OraSure contacted the sole customer via email and mail (letter dated July 21, 2016) to request return of all the product from the affected lot.
- Quantity
- 3,075 units
- Distribution
- Distributed to one customer only in US state of Georgia.
- Lot, serial or model codes
- Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 2528909
- Firm city
- Bethlehem
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28