FDA Device recall Z-1509-2016
OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near…
- FDA Device
- Class III
- terminated
- Published 2016-04-27
On 2016-04-27 the FDA classified a Class III recall of OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near… by Orasure Technologies, citing oraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received fro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1509-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-01-15 |
| Published | 2016-04-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Orasure Technologies |
| Distribution | US |
Product
OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
Reason
OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received from one of their customers. The customer reported they received the Ora Quick Ebola Visual Reference Panel instead of an OraQuick HCV Visual Reference Panel.
Identifiers
| code_info | Item Number 1001-0343, Lot # 6648737 |
|---|
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-1509-2016%22
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