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 | A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected |
| Product | C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456, |
| Quantity | 1 kit |
| Distribution | U.S.: FL |
| Initiated | 2019-04-25 |
| Classified | 2020-03-31 |
| Terminated | 2021-04-27 |
| Recall number | Z-1619-2020 |
| 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-1619-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84890/
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