Recall Z-2450-2015— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2450-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-23

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2015-07-23, terminated 2017-03-24. It names one FDA 510(k) clearance: K083463. Product: 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.. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-07-23
Terminated: 2017-03-24
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K083463 — DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL MSiemens Healthcare Diagnostics·cleared 2009-03-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.