Recall Z-0943-2021 ยท DFH Kappa, Antigen, Antiserum, Control
The Binding Site Group, Ltd.
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
| Date | Nov 18, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On 11/30/2020, the firm emailed an "Urgent Field Safety Notice" to its U.S. Customers informing them that investigations have confirmed that the quality control (QC), high and low controls, provided with specific product and lot numbers are consistently demonstrating a ~15% positive bias compared to assigned values and customers may experience QCs consistently reporting results close to the upper acceptable limits, and QC failures may occur on the affected products. Customer are instructed: 1. Users may continue to use any remaining kits of the affected product in their stock. As per the pro |
| Quantity | 213 kits in the U.S. |
| Distribution | U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit The Binding Site Group , Ltd., Aug 23, 2018 |