FDA Device recall Z-0943-2021
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
- FDA Device
- Class II
- terminated
- Published 2021-02-10
On 2021-02-10 the FDA classified a Class II recall of Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A by The Binding Site Group, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0943-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-18 |
| Published | 2021-02-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | The Binding Site Group |
| Distribution | CO, FL, IA, MA, NC, NJ, NY, OH, SD, UT |
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.
Identifiers
| code_info | Model Number: LK016.M.OPT.A UDI: 05051700019866 Lot Number: 454763 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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All The Binding Site Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0943-2021%22
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