The Binding Site Group, Ltd. recalls
Every recall we track for The Binding Site Group, Ltd. — 16 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
16 recalls since 2017.
All FDA recall records for The Binding Site Group, Ltd. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 1 | 0 | 1 |
| 2018 | 0 | 0 | 5 | 0 | 5 |
| 2019 | 0 | 0 | 5 | 0 | 5 |
| 2020 | 0 | 0 | 2 | 0 | 2 |
| 2021 | 0 | 0 | 1 | 1 | 2 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
What to do if you have a recalled The Binding Site Group, Ltd. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All The Binding Site Group, Ltd. recalls
16 shown- Lower riskMedical device
The Binding Site Group, Ltd. recalls Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product
The Binding Site Group recalls EXENT Analyser software version 1.0.20 due to potential false M-protein results. Affected units may show inaccurate test results, requiring immediate verification with a different method.
The Binding Site GroupApr 16, 2026 - Lower riskMedical device
The Binding Site Group, Ltd. recalls Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the
The Binding Site Group recalls Freelite Human Lambda Free Kit (REF LK018.S) due to calibration issues that may cause inaccurate test results. Affected units include specific lot numbers and model numbers.
The Binding Site GroupOct 15, 2021 - UnratedMedical device
The Binding Site Group, Ltd. recalls FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas
The Binding Site recalls FREELITE Human Kappa Free Kit for Roche cobas systems due to 10% positive bias in quality controls. Affected kits may give false high results. No remedy specified in recall notice.
The Binding SiteMay 20, 2021 - Lower riskMedical device
The Binding Site Group, Ltd. recalls Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
The Binding Site Group recalls Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A due to positive bias in quality control measurements. Affected units have specific model and lot numbers.
The Binding Site GroupNov 18, 2020 - Lower riskMedical device
The Binding Site Group, Ltd. recalls The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite
The Binding Site recalls The Optilite Clinical Chemistry Analyzer (model IE700) due to a software issue that may affect test result accuracy. Affected units run software versions 7.0 or 7.01.
The Binding SiteApr 9, 2020 - Lower riskMedical device
The Binding Site Group, Ltd. recalls Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI:
The Binding Site Group recalls Rheumatoid Factor (RF) Kit for false positive test results due to calibrator values over recovering. Affected kits may cause unnecessary testing.
The Binding Site GroupNov 6, 2019 - Lower riskMedical device
The Binding Site Group, Ltd. recalls Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four
The Binding Site Group recalls Optilite Rheumatoid Factor Kit (UDI: 05051700020015) due to potential false positive results in rheumatoid arthritis testing, which may cause unnecessary tests and delayed treatment.
The Binding Site GroupOct 7, 2019 - Lower riskMedical device
The Binding Site Group, Ltd. recalls OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
The Binding Site Group recalls OPTILITE IgM Kit (REF: NK012.OPT.A) due to potential calibration errors that could lead to false patient results and delayed testing.
The Binding Site GroupJul 29, 2019 - Lower riskMedical device
The Binding Site Group, Ltd. recalls C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
The Binding Site recalls C-Reactive Protein kits for SPAplus devices due to potential inaccurate test results for low concentrations. Affected kits may not detect samples below 10 mg/L correctly.
The Binding SiteApr 25, 2019 - Lower riskMedical device
The Binding Site Group, Ltd. recalls Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the
The Binding Site recalls Optilite C-Reactive Protein Kits due to potential reagent deterioration causing inaccurate test results. Affected kits include model NK044.OPT.A with lot 437705. Users should contact for guidance.
The Binding SiteFeb 19, 2019 - Lower riskMedical device
The Binding Site Group, Ltd. recalls Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM
The Binding Site recalls Human IgM Kit (for SPAPLUS) REF NK012.S due to calibration curve validation problems. Kit control values may report outside specified ranges.
The Binding SiteNov 6, 2018 - Lower riskMedical device
The Binding Site Group, Ltd. recalls VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code:
The Binding Site Group recalls VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kits due to potential false positive results in immunodeficiency testing. Affected kits may show falsely elevated antibody levels.
The Binding Site GroupAug 12, 2018 - Lower riskMedical device
The Binding Site Group, Ltd. recalls Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM
Binding Site recalls Human IgM Kit (SPAPLUS) REF NK012.S due to reduced accuracy after calibration. Affected lots 407483-1 and 407483-2 may produce inaccurate results.
The Binding SiteJul 25, 2018 - Lower riskMedical device
The Binding Site Group, Ltd. recalls Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding
The Binding Site Group recalls their Optilite Beta-2-Microglobulin Urine Kit (Ref LK043.L.OPT.A) due to inaccurate test results. This IVD kit may not meet the claimed antigen excess protection level of 760mg/L, potentially leading to incorrect diagnosis of rheumatoid arthritis or kidney disease.
The BindingMar 9, 2018 - Lower riskMedical device
The Binding Site Group, Ltd. recalls Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of
The Binding Site Group recalls Rheumatoid Factor (RF) Kit for SPAPLUS analyser due to low and high controls returning results above assigned values. This may affect rheumatoid arthritis testing accuracy.
The Binding Site GroupJan 4, 2018 - Lower riskMedical device
The Binding Site Group, Ltd. recalls Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The
The Binding Site recalls Human Alpha-1-Antitrypsin Kit for SPAPlus analyser due to potential low control values affecting test accuracy. This may impact liver and lung condition diagnosis.
The Binding SiteAug 23, 2017
The Binding Site Group, Ltd. recall questions
How many recalls has The Binding Site Group, Ltd. had?
16 recalls from The Binding Site Group, Ltd. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent The Binding Site Group, Ltd. recall?
The Binding Site Group, Ltd. recalls Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product, dated Apr 16, 2026. Every The Binding Site Group, Ltd. recall is listed on this page, newest first.
What should I do if I have a recalled The Binding Site Group, Ltd. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new The Binding Site Group, Ltd. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.