The Binding Site Group recalls

The Binding Site Group appears in 29 official U.S. recall notices indexed by RecallRadar, most recently on 2026-06-17.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXE…
  FDA Device · Class II · 2026-06-17 · The Binding Site Group
  Reason: 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 det…
• 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…
  FDA Device · Class II · 2021-12-01 · The Binding Site Group
  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…
• FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK0…
  FDA Device · Class II · 2021-07-14 · The Binding Site Group
  Reason: The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
• Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
  FDA Device · Class II · 2021-02-10 · The Binding Site Group
  Reason: 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.
• Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
  FDA Device · Class II · 2020-06-03 · The Binding Site Group
  Reason: 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 c…
• The Optilite Clinical Chemistry Analyzer
  FDA Device · Class II · 2020-05-27 · The Binding Site Group
  Reason: A software issue that may affect the analyzer's result accuracy.
• C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456
  FDA Device · Class II · 2020-04-08 · The Binding Site Group
  Reason: 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
• Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
  FDA Device · Class II · 2020-03-25 · The Binding Site Group
  Reason: 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 unnecessa…
• VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: T…
  FDA Device · Class II · 2020-03-18 · The Binding Site Group
  Reason: 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 incorr…
• OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
  FDA Device · Class II · 2020-02-26 · The Binding Site Group
  Reason: 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 patie…
• Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determin…
  FDA Device · Class II · 2019-12-18 · The Binding Site Group
  Reason: Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
• Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators an…
  FDA Device · Class II · 2018-12-19 · The Binding Site Group
  Reason: 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.
• Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators an…
  FDA Device · Class II · 2018-11-28 · The Binding Site Group
  Reason: 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 ca…
• 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., Bi…
  FDA Device · Class II · 2018-04-11 · The Binding Site Group
  Reason: The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
• Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor i…
  FDA Device · Class II · 2018-02-14 · The Binding Site Group
  Reason: The low and high controls for the product are returning results above the assigned values.
• 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.,…
  FDA Device · Class II · 2017-10-11 · The Binding Site Group
  Reason: The high control for the kit is recovering low and may be out of range for assigned values.
• Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for qualifying huma…
  FDA Device · Class II · 2017-02-01 · The Binding Site Group
  Reason: Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
• Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immu…
  FDA Device · Class II · 2017-02-01 · The Binding Site Group
  Reason: Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
• Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T This kit is intended for qualifying hum…
  FDA Device · Class II · 2017-02-01 · The Binding Site Group
  Reason: Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
• MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in s…
  FDA Device · Class II · 2017-02-01 · The Binding Site Group
  Reason: Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
• Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM This kit is intended for qualifying human IgG s…
  FDA Device · Class II · 2017-02-01 · The Binding Site Group
  Reason: Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
• Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is intended for qualifying human IgG subclasses 1,2,3 and…
  FDA Device · Class II · 2017-02-01 · The Binding Site Group
  Reason: Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
• Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 a…
  FDA Device · Class II · 2017-02-01 · The Binding Site Group
  Reason: Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
• Optilite IgG4 Kit Product Code: LK009.OPT.A
  FDA Device · Class III · 2017-02-01 · The Binding Site Group
  Reason: 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 ins…
• Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random…
  FDA Device · Class II · 2017-01-25 · The Binding Site Group
  Reason: Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
• Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases
  FDA Device · Class II · 2017-01-25 · The Binding Site Group
  Reason: Calibration curve activity has increased over time in the kit lots listed.
• Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple M…
  FDA Device · Class II · 2017-01-25 · The Binding Site Group
  Reason: A change in the calibration curve causing an increase in false prozone flags.
• Digital RID Plate Reader and Software Product Code: AD400
  FDA Device · Class II · 2017-01-25 · The Binding Site Group
  Reason: If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.
• Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit
  FDA Device · Class II · 2017-01-25 · The Binding Site Group
  Reason: 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 givin…