Method, Nephelometric, Immunoglobulins (g, A, M)

Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal

Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.

Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2

Lipemic interference failed to meet the performance specification listed within the IFU.

N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD

N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD

N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S

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

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 calibration curve. Samples have been shown to be similarly affected.

Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser

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"

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

Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.