FDA Device recall Z-2403-2016
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807
- FDA Device
- Class I
- terminated
- Published 2016-08-24
On 2016-08-24 the FDA classified a Class I recall of OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807 by Orasure Technologies, citing failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2403-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-07-20 |
| Published | 2016-08-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Orasure Technologies |
| Distribution | GA |
Product
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
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.
Identifiers
| code_info | Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2403-2016%22
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