Z-1509-2016 Class III Terminated
FDA device recall Z-1509-2016 was initiated by OraSure Technologies, Inc. on January 15, 2016 and is designated Class III. 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 custom… The recall status is terminated (terminated February 7, 2018). Affected quantity: 244 Visual Reference Panel Kits.
Recall Details
- Product Type
- Devices
- Report Date
- April 27, 2016
- Initiation Date
- January 15, 2016
- Termination Date
- February 7, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 244 Visual Reference Panel Kits
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.
Distribution Pattern
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.
Code Information
Item Number 1001-0343, Lot # 6648737