The Binding Site Group, Ltd. Recall 86926
Description: Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
The Binding Site Group, Ltd. Recall 86926 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0943-2021 |
| Event ID | 86926 |
| Event Description | Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A |
| Product Type | Devices |
| Distribution | U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided |
| Quantity | 213 kits in the U.S. |
| Recall Reason | 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. |
| Device Classification | 20210210 |
| Device Code Info | Model Number: LK016.M.OPT.A UDI: 05051700019866 Lot Number: 454763 |
| Center Classification Date | 20210201 |
| Recall Initiation Date | 20201118 |
| Recalling Firm | The Binding Site Group, Ltd. |
| Initial Notification | |
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