FDA Device recall Z-1363-2020
ADVIA Chemistry Lipase, Ref
- FDA Device
- Class II
- terminated
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class II recall of ADVIA Chemistry Lipase, Ref by Siemens Healthcare Diagnostics, citing firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1363-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-20 |
| Published | 2020-03-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as acute pancreatitis and obstruction of the pancreatic duct.
Reason
Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
Identifiers
| code_info | lot 485700 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1363-2020%22
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