OraQuick Ebola Rapid Antigen Test — Class I medical device recall Z-2403-2016
Terminated recall by OraSure Technologies, Inc., reported 2016-08-24, distributed in GA. Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive k
| Recall number | Z-2403-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OraSure Technologies, Inc., Bethlehem, PA, United States |
| Recall initiated | 2016-07-20 |
| Classified | 2016-08-17 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2017-05-10 |
| Distributed | GA |
| Quantity | 3,075 units |
| Reason classes | specification failure |
| Lot numbers | 6648965 |
| Expiration dates | 2016-10-31 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2403-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.