FDA Device recall Z-0466-2019
Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagno…
- FDA Device
- Class II
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class II recall of Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagno… by Siemens Healthcare Diagnostics, citing there is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0466-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-07 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension Vista System.
Reason
There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
Identifiers
| code_info | Lot Numbers: 18128BA, 18172BA, 18186BB |
|---|
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-0466-2019%22
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