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 | Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer. |
| Product | Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S |
| Quantity | 2,254 kits |
| Distribution | U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada |
| Initiated | 2021-10-15 |
| Classified | 2021-11-19 |
| Terminated | 2025-02-04 |
| Recall number | Z-0274-2022 |
| 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-0274-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88921/
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