Z-0943-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 10, 2021
- Initiation Date
- November 18, 2020
- Termination Date
- December 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 213 kits in the U.S.
Product Description
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
Reason for Recall
Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.
Distribution Pattern
U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided
Code Information
Model Number: LK016.M.OPT.A UDI: 05051700019866 Lot Number: 454763