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.
Reported: April 27, 2016 Initiated: January 15, 2016 #Z-1509-2016
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.
Details
- Recalling Firm
- OraSure Technologies, Inc.
- Units Affected
- 244 Visual Reference Panel Kits
- Distribution
- Nationwide Distribution -- AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MI, MO, MT, NC, ND, NE, NH, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, and WI.
- Location
- Bethlehem, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by OraSure Technologies, Inc.. Units affected: 244 Visual Reference Panel Kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 27, 2016. Severity: Low. Recall number: Z-1509-2016.
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