The Binding Site Group , Ltd.
Medical device manufacturer in Birmingham, Unit.
44510(k) clearances
0PMA approvals
29recalls
Device types
- CFN Method, Nephelometric, Immunoglobulins (G… 14
- DFH Kappa, Antigen, Antiserum, Control 4
- DCN System, Test, C-Reactive Protein 3
- DCF Albumin, Antigen, Antiserum, Control 3
- DAE Complement C9, Antigen, Antiserum, Control 2
- DHR System, Test, Rheumatoid Factor 2
- DBA Complement C1 Inhibitor (Inactivator)… 2
- PCN Immunoglobulin G Kappa Heavy And Light… 2
- OPX Immunoglobulin A Kappa Heavy & Light Chain… 2
- PDE Immunoglobulin M Kappa Heavy And Light… 2
- DEM Alpha-1-Antitrypsin, Antigen, Antiserum… 1
- SGG Mass Spectrometric, Immunoglobulins (G, A… 1
- DEB Alpha-2-Macroglobulin, Antigen, Antiserum… 1
- DEH Lambda, Antigen, Antiserum, Control 1
- DDB Ceruloplasmin, Antigen, Antiserum, Control 1
- DDG Transferrin, Antigen, Antiserum, Control 1
- JZG System, Test, Beta-2-Microglobulin… 1
- CZW Complement C3, Antigen, Antiserum, Control 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserSGG · Traditional | 10/17/2025SE |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitDFH · Traditional | 05/23/2025SE |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlusCFN · Special | 09/04/2019SE |
| K191985 | Optilite IgA KitCFN · Special | 08/19/2019SE |
| K191635 | Optilite IgM KitCFN · Special | 07/15/2019SE |
| K191465 | Human IgM Kit for use on SPAPlusCFN · Special | 06/27/2019SE |
| K190686 | Optilite IgM CSF KitCFN · Traditional | 05/28/2019SE |
| K183151 | Optilite IgA CSF KitCFN · Traditional | 01/23/2019SE |
| K180099 | Optilite High Sensitivity C-Reactive Protein KitDCN · Traditional | 10/12/2018SE |
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitDFH · Traditional | 08/23/2018SE |
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite…DCN · Traditional | 02/28/2018SE |
| K172613 | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitPCN · Traditional | 02/15/2018SE |
| K162263 | Optilite Rheumatoid Factor KitDHR · Traditional | 05/03/2017SE |
| K161982 | C-Reactive Protein Kit for use on SPAPLUSDCN · Traditional | 04/05/2017SE |
| K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUSDHR · Traditional | 12/07/2016SE |
| K161854 | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for…PCN · Traditional | 10/04/2016SE |
| K153560 | Optilite Low Level Albumin KitDCF · Traditional | 08/25/2016SE |
| K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda KitOPX · Traditional | 06/16/2016SE |
| K152389 | Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda KitPDE · Traditional | 12/18/2015SE |
| K151759 | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use…OPX · Traditional | 11/06/2015SE |
| K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 CalibratorDAE · Traditional | 08/28/2015SE |
| K150658 | Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free KitDFH · Traditional | 08/26/2015SE |
| K150526 | Optilite IgG4 KitCFN · Traditional | 05/30/2015SE |
| K143118 | Human Microalbumin kit for use on SPAPLUSDCF · Traditional | 05/26/2015SE |
| K142735 | The Optilite IgG3 kitCFN · Traditional | 12/21/2014SE |
| K140686 | Hevylite Human Igm Kappa and Lambda Kit for Use on SpaplusPDE · Traditional | 08/06/2014SE |
| K141100 | Optilite C1 Inactivator KitDBA · Traditional | 07/18/2014SE |
| K140664 | Human ALPHA2-MACROGLOBULIN Kit for Use on SpaplusDEB · Traditional | 04/16/2014SE |
| K140396 | Freelite Human Lambda Free KitDEH · Traditional | 04/16/2014SE |
| K123256 | Human ALPHA-1 Antitrypsin Kit SpaplusDEM · Traditional | 07/03/2013SE |
| K121045 | Human Albumin CSF KitDCF · Traditional | 06/19/2013SE |
| K122965 | Human Caeruloplasmin KitDDB · Traditional | 06/03/2013SE |
| K120901 | Human Iga CSF Kit for Use on SpaplusCFN · Traditional | 05/30/2013SE |
| K120750 | Human Igm CSF KitCFN · Traditional | 05/17/2013SE |
| K120749 | Human Igg CSF KitCFN · Traditional | 05/17/2013SE |
| K122304 | Human C1 Inactivator Kit for Use on SpaplusDBA · Traditional | 04/15/2013SE |
| K120056 | Human Kappa and Lambda Free Kitfor Use on the SPA Plus AnalyserDFH · Traditional | 04/01/2013SE |
| K113823 | Hevylite Human Igm Kappa and Hevylite Igm Lambda KitCFN · Traditional | 03/27/2013SE |
| K120236 | Transferrin Kit for Use on the SpaplusDDG · Traditional | 02/13/2013SE |
| K122066 | Human BETA-2 Microglobulin Urine Kit for Use on the SpaplusJZG · Special | 08/30/2012SE |
| K113349 | Human CH50 Reagent Pack for Use on the Spaplus, Human CH50 Calibrator Set for Use on the…DAE · Traditional | 07/11/2012SE |
| K100588 | Human IGA2 Kit for Use on the SpaplusCFN · Traditional | 08/16/2010SE |
| K100179 | SpaplusCZW · Traditional | 08/13/2010SE |
| K082823 | Hevylite Human Iga Kappa and Iga Lambda BN KitsCFN · Traditional | 03/01/2010SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2362-2026 Class II | Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A…It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been… | 04/16/2026Open, Classified |
| Z-0274-2022 Class II | Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human…Due to calibration curves producing a higher activity than routinely expected and that there may be a… | 10/15/2021Terminated |
| Z-2030-2021 Class II | FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie…The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to… | 05/20/2021Terminated |
| Z-0943-2021 Class II | Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.ADue to customer complaints of positive bias impacting quality control. The high and low level controls are… | 11/18/2020Terminated |
| Z-2071-2020 Class II | The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 -…A software issue that may affect the analyzer's result accuracy. | 04/09/2020Terminated |
| Z-1500-2020 Class II | Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product…It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the… | 11/06/2019Terminated |
| Z-2110-2020 Class II | Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI:…Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the… | 10/07/2019Terminated |
| Z-1327-2020 Class II | OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565There is a potential that users may experience difficulty validating the calibration of the kit. This is… | 07/29/2019Terminated |
| Z-1619-2020 Class II | C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI…A reagent in C reactive protein kits is not performing to specification and samples with known… | 04/25/2019Terminated |
| Z-0671-2020 Class II | Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent…Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits | 02/19/2019Terminated |
| Z-0604-2019 Class II | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction…Firm is offering advice to customers experiencing challenges when validating the calibration curve of the… | 11/06/2018Terminated |
| Z-1469-2020 Class II | VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro…A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with findings of… | 08/12/2018Terminated |
| Z-0477-2019 Class II | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction…After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a… | 07/25/2018Terminated |
| Z-1301-2018 Class II | Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm…The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the… | 03/09/2018Terminated |
| Z-0553-2018 Class II | Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the…The low and high controls for the product are returning results above the assigned values. | 01/04/2018Terminated |
| Z-0002-2018 Class II | Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The…The high control for the kit is recovering low and may be out of range for assigned values. | 08/23/2017Terminated |
| Z-1089-2017 Class III | Optilite IgG4 Kit Product Code: LK009.OPT.AA change to the lower end of the measuring range and product insert did not reflect the change.The measuring… | 12/23/2016Terminated |
| Z-1053-2017 Class II | Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S…A change in the calibration curve causing an increase in false prozone flags. | 10/28/2016Terminated |
| Z-1043-2017 Class II | Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing…Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower… | 07/05/2016Terminated |
| Z-1018-2017 Class II | Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko…Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully… | 05/13/2015Terminated |
| Z-1073-2017 Class II | MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | 09/11/2014Terminated |
| Z-1072-2017 Class II | Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | 09/11/2014Terminated |
| Z-1071-2017 Class II | Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | 09/11/2014Terminated |
| Z-1070-2017 Class II | Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | 09/11/2014Terminated |
| Z-1069-2017 Class II | Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | 09/11/2014Terminated |
| Z-1068-2017 Class II | Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | 09/11/2014Terminated |
| Z-1067-2017 Class II | Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | 09/11/2014Terminated |
| Z-1050-2017 Class II | Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and…Calibration curve activity has increased over time in the kit lots listed. | 11/28/2012Terminated |
| Z-1055-2017 Class II | Digital RID Plate Reader and Software Product Code: AD400If a control ring is marked after reading, the software will not flag results that are out of the specified… | 10/09/2012Terminated |