System, Test, Beta-2-microglobulin Immunological

Atellica CH 2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma.

Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH 2-Microglobulin (B2M) reagent.

Dimension Vista System

Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista B2MIC Flex reagent cartridge: Dimension Vista System Flex reagent cartridge and urine stabilizer B2MIC. In the unlikely event that a patient result is generated, a suppressed result would be in conflict with the patients clinical status and other markers of renal injury.

Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC);

customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potential for falsely depressed beta2-Microglobulin results on the Dimension Vista system due to assay reagent contamination.

Atellica CH 2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma

2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L

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 product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.

ST-AIA PACK BMG; Part Number:025259

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.