Rheumatoid Factor — Class II medical device recall Z-0553-2018
Terminated recall by The Binding Site Group, Ltd., reported 2018-02-14, distributed in CA. The low and high controls for the product are returning results above the assigned values.
| Recall number | Z-0553-2018 |
|---|---|
| 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 | 2018-01-04 |
| Classified | 2018-02-08 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2020-06-09 |
| Distributed | CA |
| UPC / GTIN / UDI-DI | 05051700018319 |
| Lot numbers | 416595 |
Product
Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings
Reason for recall
The low and high controls for the product are returning results above the assigned values.
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-0553-2018. 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.