FDA Device recall Z-1540-2018
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test f…
- FDA Device
- Class II
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class II recall of Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test f… by Siemens Healthcare Diagnostics, citing may produce erroneously low results from specific well sets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1540-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-30 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
Reason
May produce erroneously low results from specific well sets.
Identifiers
| code_info | Lot # 17171BD, UDI # (UDI) 0084276801561817171BD18062010445160 EXP. 06-20-2018 |
|---|
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-1540-2018%22
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