The Binding Site Group
United KingdomFDA applicant, unverified
Part of The Binding Site Group Ltd
The Binding Site Group is a medical device manufacturer, with 288 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I) and 29 FDA recalls as of 14 Nov 2026.
- Devices
- 288
- FDA recalls
- 291 ongoing
Registry facts
- Registries
- FDA GUDID 287
- EUDAMED 15
- FDA 510(k) 1
- Device classes
- FDA Class II 189
- FDA Class I 67
- FDA recalls
- Sites and related companies
At a glance
Market reach
- United States
- FDA recalls
What The Binding Site Group makes
The company manufactures in vitro diagnostic (IVD) kits and reagents for measuring immunoglobulin subclasses (IgG1–IgG4), total immunoglobulins (IgG, IgA, IgM), kappa/lambda free light chains, beta-2-microglobulin, and other serum proteins. Products include nephelometry/turbidimetry kits for automated analyzers (e.g., Siemens BNII, Beckman AU series) and radial immunodiffusion/precipitation assays. Controls and sample sets for quality assurance are also provided, alongside specialized reagents like antistreptolysin O and alpha-1-acid glycoprotein assays.
These products are regulated under US FDA 510(k) and UDI requirements, spanning Class I and Class II devices. The manufacturer’s portfolio is listed in the FDA’s 510(k) and UDI databases, reflecting compliance with US regulatory pathways. The company operates from the United States.
Catalogue
Search and filter all 288 devicesShowing 1-50 of 288
FDA recalls
FDA recall records list 29 recalls initiated by The Binding Site Group, the earliest on 2012-10-09 and the most recent on 2026-04-16. By recorded status: 1 ongoing and 28 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, mechanical integrity and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 5
- 2019 5
- 2020 2
- 2021 2
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 1
2026
- 16 Apr 2026 Z-2362-2026 Class II Ongoing It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.
2021
- 15 Oct 2021 Z-0274-2022 Class II Terminated 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.
- 20 May 2021 Z-2030-2021 Class II Terminated The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
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2020
- 18 Nov 2020 Z-0943-2021 Class II Terminated Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.
- 9 Apr 2020 Z-2071-2020 Class II Terminated A software issue that may affect the analyzer's result accuracy.
2019
- 6 Nov 2019 Z-1500-2020 Class II Terminated It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.
- 7 Oct 2019 Z-2110-2020 Class II Terminated Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment.
- 29 Jul 2019 Z-1327-2020 Class II Terminated There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.
- 25 Apr 2019 Z-1619-2020 Class II Terminated 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
- 19 Feb 2019 Z-0671-2020 Class II Terminated Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
Show the 25 most recent of 29 recalls
2018
- 6 Nov 2018 Z-0604-2019 Class II Terminated Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.
- 12 Aug 2018 Z-1469-2020 Class II Terminated A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with findings of a positive bias with kit controls. Patient sample results may be affected with falsely elevated results incorrectly indicating a protective level of anti-Hib antibody in the assessment of immunodeficiency.
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- 25 Jul 2018 Z-0477-2019 Class II Terminated After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve. Samples have been shown to be similarly affected.
- 9 Mar 2018 Z-1301-2018 Class II Terminated The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
- 4 Jan 2018 Z-0553-2018 Class II Terminated The low and high controls for the product are returning results above the assigned values.
2017
- 23 Aug 2017 Z-0002-2018 Class II Terminated The high control for the kit is recovering low and may be out of range for assigned values.
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- 23 Aug 2017 Z-0002-2018 Class II Terminated The high control for the kit is recovering low and may be out of range for assigned values.
2016
- 23 Dec 2016 Z-1089-2017 Class III Terminated A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert
- 28 Oct 2016 Z-1053-2017 Class II Terminated A change in the calibration curve causing an increase in false prozone flags.
- 5 Jul 2016 Z-1043-2017 Class II Terminated Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards.
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2015
- 13 May 2015 Z-1018-2017 Class II Terminated Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
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- 13 May 2015 Z-1018-2017 Class II Terminated Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
2014
- 11 Sep 2014 Z-1067-2017 Class II Terminated Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
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- 11 Sep 2014 Z-1068-2017 Class II Terminated Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
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- 11 Sep 2014 Z-1069-2017 Class II Terminated Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
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- 11 Sep 2014 Z-1070-2017 Class II Terminated Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
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- 11 Sep 2014 Z-1071-2017 Class II Terminated Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
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- 11 Sep 2014 Z-1067-2017 Class II Terminated Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Frequently asked questions
How many devices does The Binding Site Group have in the registry?
The registry currently lists 288 devices for The Binding Site Group. Devices recorded under merged duplicate company entries are counted once.
Which registries list The Binding Site Group's devices?
Among its 50 most recently registered devices, The Binding Site Group has devices listed in EUDAMED (2 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do The Binding Site Group's devices fall under?
Among its 50 most recently registered devices, the classes recorded for The Binding Site Group's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for The Binding Site Group?
FDA recall records list 29 recalls initiated by The Binding Site Group, the most recent initiated on 16 Apr 2026. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from The Binding Site Group in the registry?
The most recently registered devices listed for The Binding Site Group include EXENT® Analyser IE800.A, Immunoglobulin Isotypes (GAM) for the EXENT Analyser MSR801.M.A, Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems LK016.CB.A and Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems LK018.CB.A.