Dimension Vista System B2 Microglobulin Flex reagent cartridge and… — Class II medical device recall Z-1030-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-03-09, distributed in CA. Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibratio
| Recall number | Z-1030-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2015-11-03 |
| Classified | 2016-03-01 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2017-01-13 |
| Distributed | CA |
| Quantity | 1,637 units |
| Reason classes | potency |
| Lot numbers | 15037MA, 15246MA |
| Model numbers | 10445889, K7024 |
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, 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.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.