Human Lambda Free SPAPlus Kit Product Code: LK018 — Class II medical device recall Z-1050-2017
Terminated recall by The Binding Site Group, Ltd., reported 2017-01-25, distributed in AZ, CA, GA, HI, ID, MA, NY, OK…. Calibration curve activity has increased over time in the kit lots listed.
| Recall number | Z-1050-2017 |
|---|---|
| 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 | 2012-11-28 |
| Classified | 2017-01-19 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2017-03-03 |
| Distributed | AZ, CA, GA, HI, ID, MA, NY, OK, PA, TX, UT |
| Countries outside the US | AU, BE, BG, DK, ES, FR, HK, IE, IL, IT, JP, NZ, TW |
| Quantity | 1,002 |
| Lot numbers | 323278, 327963 |
Product
Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
Reason for recall
Calibration curve activity has increased over time in the kit lots listed.
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-1050-2017. 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.