Recall Z-1509-2016— OraSure Technologies, Inc.
Class III · Terminated
Class III FDA medical device recall by OraSure Technologies, Inc., initiated 2016-01-15, terminated 2018-02-07. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- OraSure Technologies, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-01-15
- Terminated
- 2018-02-07
- Firm location
- Bethlehem, PA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.