Siemens Dimension Vista B2 Microglobulin Reagent Cartridge Recall
Siemens Healthcare Diagnostics is recalling Dimension Vista B2 Microglobulin reagent cartridges due to increased abnormal assay errors and calibration failures that may produce inaccurate patient results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical diagnostic device where inaccurate results could lead to incorrect clinical decisions, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer (Catalog #K7024). The recall affects 1,637 units, specifically Lot #15246MA, which was distributed in the United States (California). Other lots (15037MA, 15175MA, 15204MA, and 15267MA) were distributed in foreign markets.
The recall was initiated because Siemens confirmed an increase in the rate of "Abnormal Assay" errors and calibration failures with the affected reagent cartridges. The B2MIC method is an in vitro diagnostic test used to measure B2-microglobulin in human serum, plasma, and urine to aid in the diagnosis of active rheumatoid arthritis and kidney disease.
If a patient result is generated from the affected product, it may be a suppressed result that conflicts with the patient's clinical status and other markers of renal injury. Healthcare facilities should stop using the affected product and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- 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, heparinize
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,637
Distribution
Distributed in 1 state:
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