Z-0943-2021 Class II Terminated
FDA device recall Z-0943-2021 was initiated by The Binding Site Group, Ltd. on November 18, 2020 and is designated Class II. 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. The recall status is terminated (terminated December 23, 2024). Affected quantity: 213 kits in the U.S..
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