Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018 — Class II medical device recall Z-1053-2017
Terminated recall by The Binding Site Group, Ltd., reported 2017-01-25, distributed nationwide. A change in the calibration curve causing an increase in false prozone flags.
| Recall number | Z-1053-2017 |
|---|---|
| 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 | 2016-10-28 |
| Classified | 2017-01-19 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2017-07-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 3,088 |
| Lot numbers | 400012, 400257 |
Product
Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
Reason for recall
A change in the calibration curve causing an increase in false prozone flags.
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-1053-2017. 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.