FDA Device recall Z-1030-2016
Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usage…
- FDA Device
- Class II
- terminated
- Published 2016-03-09
On 2016-03-09 the FDA classified a Class II recall of Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usage… by Siemens Healthcare Diagnostics, citing 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: Dim….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1030-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-03 |
| Published | 2016-03-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | CA |
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
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.
Identifiers
| code_info | Lot #: 15037MA - foreign 15175MA - foreign 15204MA- foreign 15246MA (Distributed in US) 15267MA - foreign |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1030-2016%22
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