Every recall we track for The Binding Site Group, Ltd. — 16 in all — plus the complaints and injury reports the public filed about them.
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 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 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 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 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 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 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 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 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 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 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 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.
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 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 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.
