Optilite Freelite Mx Kappa Free Kit REF LK016 — Class II medical device recall Z-0943-2021
Terminated recall by The Binding Site Group, Ltd., reported 2021-02-10, distributed in CO, FL, IA, MA, NC, NJ, NY, OH…. Due to customer complaints of positive bias impacting quality control. The high and low level controls are dem
| Recall number | Z-0943-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Binding Site Group, Ltd., Birmingham, United Kingdom |
| Recall initiated | 2020-11-18 |
| Classified | 2021-02-01 |
| Reported by FDA | 2021-02-10 |
| Terminated | 2024-12-23 |
| Distributed | CO, FL, IA, MA, NC, NJ, NY, OH, SD, UT |
| Quantity | 213 kits |
| UPC / GTIN / UDI-DI | 05051700019866 |
| Lot numbers | 454763 |
| Model numbers | LK016.M.OPT.A |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0943-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.