Rheumatoid Factor — Class II medical device recall Z-1500-2020
Terminated recall by The Binding Site Group, Ltd., reported 2020-03-25, distributed in CA. It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the ref
| Recall number | Z-1500-2020 |
|---|---|
| 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 | 2019-11-06 |
| Classified | 2020-03-13 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2022-09-08 |
| Distributed | CA |
| Quantity | 30 kits |
| UPC / GTIN / UDI-DI | 05051700018319 |
| Lot numbers | 428217 |
| Expiration dates | 2020-04-30 |
Product
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
Reason for recall
It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.
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-1500-2020. 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.