The Binding Site Group, Ltd.
FDA Regulatory Profile
The Binding Site Group, Ltd. appears in FDA public data with 29 recalls, 44 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2362-2026, Class II) was initiated on April 16, 2026. Its most recent 510(k) clearance was granted on October 17, 2025.
Summary
- Total Recalls
- 29
- 510(k) Clearances
- 44
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2362-2026 | Class II | Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Ve | April 16, 2026 |
| Z-0274-2022 | Class II | Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit | October 15, 2021 |
| Z-2030-2021 | Class II | FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) | May 20, 2021 |
| Z-0943-2021 | Class II | Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A | November 18, 2020 |
| Z-2071-2020 | Class II | The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usa | April 9, 2020 |
| Z-1500-2020 | Class II | Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. | November 6, 2019 |
| Z-2110-2020 | Class II | Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit | October 7, 2019 |
| Z-1327-2020 | Class II | OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565 | July 29, 2019 |
| Z-1619-2020 | Class II | C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456, | April 25, 2019 |
| Z-0671-2020 | Class II | Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended | February 19, 2019 |
| Z-0604-2019 | Class II | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sh | November 6, 2018 |
| Z-1469-2020 | Class II | VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, | August 12, 2018 |
| Z-0477-2019 | Class II | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sh | July 25, 2018 |
| Z-1301-2018 | Class II | Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the | March 9, 2018 |
| Z-0553-2018 | Class II | Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative i | January 4, 2018 |
| Z-0002-2018 | Class II | Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on t | August 23, 2017 |
| Z-1089-2017 | Class III | Optilite IgG4 Kit Product Code: LK009.OPT.A | December 23, 2016 |
| Z-1053-2017 | Class II | Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids | October 28, 2016 |
| Z-1043-2017 | Class II | Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit. | July 5, 2016 |
| Z-1018-2017 | Class II | Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chem | May 13, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | October 17, 2025 |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | May 23, 2025 |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlus | September 4, 2019 |
| K191985 | Optilite IgA Kit | August 19, 2019 |
| K191635 | Optilite IgM Kit | July 15, 2019 |
| K191465 | Human IgM Kit for use on SPAPlus | June 27, 2019 |
| K190686 | Optilite IgM CSF Kit | May 28, 2019 |
| K183151 | Optilite IgA CSF Kit | January 23, 2019 |
| K180099 | Optilite High Sensitivity C-Reactive Protein Kit | October 12, 2018 |
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | August 23, 2018 |
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Prote | February 28, 2018 |
| K172613 | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit | February 15, 2018 |
| K162263 | Optilite Rheumatoid Factor Kit | May 3, 2017 |
| K161982 | C-Reactive Protein Kit for use on SPAPLUS | April 5, 2017 |
| K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUS | December 7, 2016 |
| K161854 | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SP | October 4, 2016 |
| K153560 | Optilite Low Level Albumin Kit | August 25, 2016 |
| K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit | June 16, 2016 |
| K152389 | Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit | December 18, 2015 |
| K151759 | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS | November 6, 2015 |