The Binding Site Group, Ltd.
Complete recall history across all FDA and CPSC categories — 28 total recalls
The Binding Site Group, Ltd. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (28)
FDA medical device enforcement actions by The Binding Site Group, Ltd.
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 15, 2021 | Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite... | Due to calibration curves producing a higher activity than routinely expected... | Class II |
| May 20, 2021 | FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Fre... | The high and low level "Quality Controls" demonstrate a positive bias of ap... | Class II |
| Nov 18, 2020 | Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A | Due to customer complaints of positive bias impacting quality control. The h... | Class II |
| Apr 9, 2020 | The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051... | A software issue that may affect the analyzer's result accuracy. | Class II |
| Nov 6, 2019 | Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, P... | It has been identified that the rheumatoid factor (RF) calibrator values over... | Class II |
| Oct 7, 2019 | Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI... | Assigned Rheumatoid Factor (RF) calibrator value for calibrator component inc... | Class II |
| Jul 29, 2019 | OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565 | There is a potential that users may experience difficulty validating the cali... | Class II |
| Apr 25, 2019 | C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (0... | A reagent in C reactive protein kits is not performing to specification and s... | Class II |
| Feb 19, 2019 | Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Prot... | Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Prot... | Class II |
| Nov 6, 2018 | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists... | Firm is offering advice to customers experiencing challenges when validating ... | Class II |
| Aug 12, 2018 | VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For i... | A deterioration of performance was identified with influenza type B Enzyme Im... | Class II |
| Jul 25, 2018 | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists... | After running the calibration curve, the recovery of the IgM kit control resu... | Class II |
| Mar 9, 2018 | Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD.... | The product is not meeting the antigen excess protection claim of up to 760mg... | Class II |
| Jan 4, 2018 | Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended... | The low and high controls for the product are returning results above the ass... | Class II |
| Aug 23, 2017 | Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034... | The high control for the kit is recovering low and may be out of range for as... | Class II |
| Dec 23, 2016 | Optilite IgG4 Kit Product Code: LK009.OPT.A | A change to the lower end of the measuring range and product insert did not r... | Class III |
| Oct 28, 2016 | Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, L... | A change in the calibration curve causing an increase in false prozone flags. | Class II |
| Jul 5, 2016 | Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Pr... | Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L t... | Class II |
| May 13, 2015 | Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientif... | Potential risk of the Optilite lid/cover falling suddenly and causing injury ... | Class II |
| Sep 11, 2014 | Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ... | Customer complaints identified that samples containing extremely high IgG4 le... | Class II |
| Sep 11, 2014 | Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II... | Customer complaints identified that samples containing extremely high IgG4 le... | Class II |
| Sep 11, 2014 | Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"600... | Customer complaints identified that samples containing extremely high IgG4 le... | Class II |
| Sep 11, 2014 | Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Produ... | Customer complaints identified that samples containing extremely high IgG4 le... | Class II |
| Sep 11, 2014 | MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is inte... | Customer complaints identified that samples containing extremely high IgG4 le... | Class II |
| Sep 11, 2014 | Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 L... | Customer complaints identified that samples containing extremely high IgG4 le... | Class II |
| Sep 11, 2014 | Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit ... | Customer complaints identified that samples containing extremely high IgG4 le... | Class II |
| Nov 28, 2012 | Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in th... | Calibration curve activity has increased over time in the kit lots listed. | Class II |
| Oct 9, 2012 | Digital RID Plate Reader and Software Product Code: AD400 | If a control ring is marked after reading, the software will not flag results... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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