Class I — OraSure Technologies, Inc.
| Recalling firm | ORASURE TECHNOLOGIES, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| 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. |
| Product | OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses. |
| Quantity | 3,075 units |
| Distribution | Distributed to one customer only in US state of Georgia. |
| Initiated | 2016-07-20 |
| Classified | 2016-08-17 |
| Terminated | 2017-05-10 |
| Recall number | Z-2403-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — OraSure Technologies, Inc. (Z-2403-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74843/
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