Manufacturer

The Binding Site Group, Ltd.

29 recalls in our database name The Binding Site Group, Ltd. as the manufacturing or recalling firm.

What the numbers show

Total: 29
Critical: 0
Severe: 0
Most recent: 2026-06-17

Of the 29 recalls from The Binding Site Group, Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 29

HighFDA (Devices)·Z-2362-2026·2026-06-17
EXENT Analyser marked plates as passed without performing quality control
An EXENT Analyser is being recalled after plates 2 and 3 were marked as passed although quality control appeared not to have been performed, despite samples being measured.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0274-2022·2021-12-01
Freelite Human Lambda Free Kit Recalled for Calibration Curve Inaccuracy
The Binding Site Group recalled 2,254 Freelite Human Lambda Free Kits due to calibration curve issues that may produce higher-than-expected activity readings and affect measurement accuracy.
Product
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
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-2030-2021·2021-07-14
FREELITE Kappa Free Kit quality control bias recall
The Binding Site Group is recalling the FREELITE Human Kappa Free Kit due to quality control bias of approximately 10% compared to assigned values. Specific lot numbers distributed worldwide are affected.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0943-2021·2021-02-10
Binding Site recalls Optilite Freelite Mx Kappa Free Kits for quality control bias
The Binding Site Group is recalling 213 Optilite Freelite Mx Kappa Free Kits in the U.S. due to customer complaints of positive bias affecting quality control.
Product
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2110-2020·2020-06-03
Binding Site Recalls Optilite Rheumatoid Factor Kits Due to Calibrator Error
The Binding Site Group is recalling 478 Optilite Rheumatoid Factor Kits because a calibrator component over-recovers by 7%, potentially causing false positive results.
Product
Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-2071-2020·2020-05-27
Binding Site Optilite Clinical Chemistry Analyzer Recalled for Software Accuracy Issue
The Binding Site Group is recalling 36 Optilite Clinical Chemistry Analyzers due to a software issue that may affect result accuracy.
Product
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 th
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1619-2020·2020-04-08
Binding Site C-Reactive Protein Kit Recalled for Reagent Performance Issues
The Binding Site Group is recalling C-Reactive Protein Kits because a reagent is not performing to specification, potentially affecting low-concentration samples.
Product
C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1500-2020·2020-03-25
Binding Site Group Recalls Rheumatoid Factor Kits Due to Calibration Error
The Binding Site Group is recalling 30 Rheumatoid Factor kits distributed in California because calibration errors may cause falsely abnormal test results.
Product
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1469-2020·2020-03-18
Binding Site Recalls VaccZyme Human Anti-Haemophilus Influenza Type B Assay Kits
The Binding Site Group is recalling 462 VaccZyme assay kits due to performance deterioration that may cause falsely elevated antibody results.
Product
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 polysaccha
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1327-2020·2020-02-26
Binding Site OPTILITE IgM Kit Recalled for Potential Calibration Issues
The Binding Site Group is recalling OPTILITE IgM Kits due to potential calibration difficulties that may cause false patient results and testing delays.
Product
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Category
Medical Device
Distribution
28 states
ModerateFDA (Devices)·Z-0671-2020·2019-12-18
Binding Site Recalls Optilite C-Reactive Protein Kits Due to Deterioration
The Binding Site Group is recalling 10 Optilite C-Reactive Protein Kits because the reagent has deteriorated. The kits were distributed in California and Georgia.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0604-2019·2018-12-19
Binding Site Human IgM Kit Recalled for Calibration Curve Validation Issues
The Binding Site Group is recalling 60 units of Human IgM Kits due to challenges in validating the calibration curve, indicated by control values outside specified ranges.
Product
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 an
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-0477-2019·2018-11-28
Binding Site Human IgM Kit Recalled for Reduced Accuracy
The Binding Site Group is recalling 108 units of Human IgM Kits due to reduced accuracy in control results and potential out-of-range readings.
Product
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 an
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1301-2018·2018-04-11
Binding Site Optilite Beta-2-Microglobulin Urine Kit Recalled for Performance Defect
The Binding Site Group is recalling 20 Optilite Beta-2-Microglobulin Urine Kits because they do not meet the stated antigen excess protection claim.
Product
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-microglo
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0553-2018·2018-02-14
Binding Site Rheumatoid Factor Kit Recalled for Control Value Deviations
The Binding Site Group is recalling Rheumatoid Factor kits because low and high controls are returning results above assigned values.
Product
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 t
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0002-2018·2017-10-11
Binding Site Alpha-1-Antitrypsin Kit Recalled for Low Control Recovery
The Binding Site Group is recalling 361 Human Alpha-1-Antitrypsin Kits because the high control may recover low and fall out of range.
Product
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
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1067-2017·2017-02-01
Binding Site Human IgG Subclass Kit Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG Subclass Kits because they may produce falsely low results for patients with extremely high IgG4 levels.
Product
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
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1069-2017·2017-02-01
Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield falsely low results for samples with extremely high IgG4 levels.
Product
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 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal pro
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1072-2017·2017-02-01
Binding Site IgG Subclass Reagent Kits Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG Subclass Liquid Reagent Kits because high IgG4 levels can cause spuriously low test results.
Product
Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T 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 immunoglobuli
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1071-2017·2017-02-01
Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield spuriously low results for samples with extremely high IgG4 levels.
Product
Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T 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 ai
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1070-2017·2017-02-01
Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield spuriously low results for samples with extremely high IgG4 levels.
Product
Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P Product Code LK009.H/LK001.H This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1068-2017·2017-02-01
Binding Site IgG4 Subclass Kit Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG4 Subclass kits because high IgG4 levels can cause spuriously low results.
Product
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 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabol
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1073-2017·2017-02-01
Binding Site IgG4 Kit Recalled for Inaccurate Results in High Levels
The Binding Site Group is recalling MininephThl Human IgG4 Kits because samples with extremely high IgG4 levels may yield spuriously low results.
Product
MininephThl Human lgG4 Kit Product Code: ZK009.LR 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
Category
Medical Device
Distribution
6 states
LowFDA (Devices)·Z-1089-2017·2017-02-01
Binding Site IgG4 Kit Recalled for Incorrect Product Insert Information
The Binding Site Group is recalling Optilite IgG4 Kits because the product insert does not reflect a change to the measuring range.
Product
Optilite IgG4 Kit Product Code: LK009.OPT.A
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1053-2017·2017-01-25
Freelite Human Lambda Free Kit Recalled for Calibration Curve Error
The Binding Site Group is recalling Freelite Human Lambda Free Kits due to a calibration curve change that causes an increase in false prozone flags.
Product
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
Category
Medical Device
Distribution
Distributed nationwide