FDA Device recall Z-0465-2019
Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test fo…
- FDA Device
- Class II
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class II recall of Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test fo… 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-0465-2019 |
| 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 Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension¿ clinical chemistry 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: GD9002, GA9003, GB9032, GA9038 |
|---|
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-0465-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.