Binding Site Optilite Beta-2-Microglobulin Urine Kit — Class II medical device recall Z-1301-2018
Terminated recall by The Binding Site Group, Ltd., reported 2018-04-11, distributed in CA. The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions
| Recall number | Z-1301-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Binding Site Group, Ltd., Birmingham, N/A, United Kingdom |
| Recall initiated | 2018-03-09 |
| Classified | 2018-04-03 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2020-06-22 |
| Distributed | CA |
| Quantity | 20 kits |
| UPC / GTIN / UDI-DI | 05051700017688 |
| Lot numbers | 407460 |
| Model numbers | LK043.L.OPT.A |
Product
Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings.
Reason for recall
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
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-1301-2018. 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.