Freelite Human Lambda Free Kit — Class II medical device recall Z-0274-2022
Terminated recall by The Binding Site Group, Ltd., reported 2021-12-01, distributed in CA, CO, FL, IL, IN, KY, LA, MI…. Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease
| Recall number | Z-0274-2022 |
|---|---|
| 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 | 2021-10-15 |
| Classified | 2021-11-19 |
| Reported by FDA | 2021-12-01 |
| Terminated | 2025-02-04 |
| Distributed | CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX, VA |
| Countries outside the US | CA |
| Quantity | 2,254 kits |
| UPC / GTIN / UDI-DI | 05051700006477, 05051700012201 |
| Lot numbers | 472664, 472776 |
| Model numbers | LK018.10S, LK018.S |
Product
Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
Reason for recall
Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.
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-0274-2022. 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.