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 rheumatoid arthritis and kidney disease.
Enforcement
- Recall Number
- Z-1030-2016
- Event ID
- 73080
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 9, 2016
- Initiation Date
- November 3, 2015
- Classification Date
- March 1, 2016
- Termination Date
- January 13, 2017
- Address
- 500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States
Description
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 rheumatoid arthritis and kidney disease.
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.
Lot #: 15037MA - foreign 15175MA - foreign 15204MA- foreign 15246MA (Distributed in US) 15267MA - foreign
Worldwide Distribution and US in the state of CA.
1637 units.