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 | The low and high controls for the product are returning results above the assigned values. |
| 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 |
| Quantity | 49 kits to the U.S. office (32 kits further distributed) |
| Distribution | US Distribution was made to CA. There was no foreign/military/government distribution. |
| Initiated | 2018-01-04 |
| Classified | 2018-02-08 |
| Terminated | 2020-06-09 |
| Recall number | Z-0553-2018 |
| 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-0553-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78934/
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