Class II — The Binding Site Group, Ltd.
| Recalling firm | THE BINDING SITE, INC. |
|---|---|
| Registered facility | THE BINDING SITE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319 |
| Quantity | 30 kits |
| Distribution | Distributed in CA. |
| Initiated | 2019-11-06 |
| Classified | 2020-03-13 |
| Terminated | 2022-09-08 |
| Recall number | Z-1500-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — The Binding Site Group, Ltd. (Z-1500-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84909/
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