Optilite Freelite Lambda Free Kit Product Code: LK018 — Class II medical device recall Z-1043-2017
Terminated recall by The Binding Site Group, Ltd., reported 2017-01-25, distributed in AR, CA, GA, KY, NC, PA, VA. Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than
| Recall number | Z-1043-2017 |
|---|---|
| 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 | 2016-07-05 |
| Classified | 2017-01-18 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2017-07-03 |
| Distributed | AR, CA, GA, KY, NC, PA, VA |
| Countries outside the US | BE, CZ, DE, ES, FR, GB, IT, PT |
| Quantity | 809 kits |
| Lot numbers | 405566, 405567 |
Product
Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
Reason for recall
Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards.
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-1043-2017. 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.