Recall Z-0943-2021— The Binding Site Group, Ltd.
Class II · Terminated
Class II FDA medical device recall by The Binding Site Group, Ltd., initiated 2020-11-18, terminated 2024-12-23. It names one FDA 510(k) clearance: K173732. Product: Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A. 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..
- Recalling firm
- The Binding Site Group, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-18
- Terminated
- 2024-12-23
- Firm location
- Birmingham, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.