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The Binding Site Group, Ltd. has 23 FDA enforcement events on this register (29 product records) between 2012 and 2026: 23 device; the busiest year was 2018 with 5.
0% of its events are Class I; the most common class is Class II (22). 1 event is listed as ongoing; the recalling firm's address is in N/A.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
Initiated Product (first record) Type Class Records Status 16 Apr 2026 Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays. Device Class II 1 Ongoing 15 Oct 2021 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 Device Class II 1 Terminated 20 May 2021 FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096 Device Class II 1 Terminated 18 Nov 2020 Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A Device Class II 1 Terminated 9 Apr 2020 The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. Device Class II 1 Terminated 6 Nov 2019 Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319 Device Class II 1 Terminated 7 Oct 2019 Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components) Device Class II 1 Terminated 29 Jul 2019 OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565 Device Class II 1 Terminated 25 Apr 2019 C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456, Device Class II 1 Terminated 19 Feb 2019 Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to… Device Class II 1 Terminated 6 Nov 2018 Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid… Device Class II 1 Terminated 12 Aug 2018 VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide, present in human serum.… Device Class II 1 Terminated 25 Jul 2018 Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid… Device Class II 1 Terminated 9 Mar 2018 Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site… Device Class II 1 Terminated 4 Jan 2018 Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with… Device Class II 1 Terminated 23 Aug 2017 Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of… Device Class II 1 Terminated 23 Dec 2016 Optilite IgG4 Kit Product Code: LK009.OPT.A Device Class III 1 Terminated 28 Oct 2016 Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases Device Class II 1 Terminated 5 Jul 2016 Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit. Device Class II 1 Terminated 13 May 2015 Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test system, is intended for in… Device Class II 1 Terminated 11 Sep 2014 Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the… Device Class II 7 Terminated 28 Nov 2012 Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases. Device Class II 1 Terminated 9 Oct 2012 Digital RID Plate Reader and Software Product Code: AD400 Device Class II 1 Terminated
By type and class Class I: 0% of this firm's events; 18% of all events on the register.
Events by year Enforcement events for The Binding Site Group, Ltd. by year initiated. Questions and answers How many FDA recalls has The Binding Site Group, Ltd. had? 23 enforcement events (29 product records) on this register, 2012–2026: 23 device.
Are any The Binding Site Group, Ltd. recalls ongoing? 1 event is listed as ongoing in the current openFDA export.
What class are The Binding Site Group, Ltd. recalls? 22 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from? openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology .