Recall Z-1030-2016 ยท JZG System, Test, Beta-2-Microglobulin Immunological
Siemens Healthcare Diagnostics, Inc.
Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA 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
| Date | Mar 1, 2016 (initiated Nov 3, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent an Urgent Medical Device Recall dated November 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use and discard your remaining inventory of the affected product. Indicate your replacement product needs on the attached Field Correction Effectiveness Check Form and return. For questions call Siemens Customer Care Center- Technical Solutions at 800-441-9250 or your local Siemens technical support representative. |
| Quantity | 1637 units. |
| Distribution | Worldwide Distribution and US in the state of CA. |
| 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 |