Recall Z-2450-2015 ยท JZG System, Test, Beta-2-Microglobulin Immunological
Siemens Healthcare Diagnostics, Inc.
Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.
| Date | Aug 22, 2015 (initiated Jul 23, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Environmental control |
| Action | Siemens sent an Urgent Medical Device Correction letter dated July 2015 to all affected customers. The letter identified the affected product, problem, risk to health, and actions to be taken by customers. For questions contact your Customer Care Center - Technical Solutions at 1-800-441-9250 or your local Siemens technical support representative. |
| Quantity | Total 1655 units |
| Distribution | US Nationwide Distribution in the states of TN, AZ, CT, Fl, CA, NY and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083463 | DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M Siemens Healthcare Diagnostics, Mar 13, 2009 |