Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagno…

Recall date

July 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2450-2015

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

US Nationwide Distribution in the states of TN, AZ, CT, Fl, CA, NY and WI

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B¿2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.