OraQuick HCV Visual Reference Panel Intended to assist new operation… — Class III medical device recall Z-1509-2016
Terminated recall by OraSure Technologies, Inc., reported 2016-04-27, distributed nationwide. OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Vi
| Recall number | Z-1509-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OraSure Technologies, Inc., Bethlehem, PA, United States |
| Recall initiated | 2016-01-15 |
| Classified | 2016-04-18 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2018-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 244 visual |
| Lot numbers | 6648737 |
| Model numbers | 1001-0343 |
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 for recall
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.
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-1509-2016. 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.