ADVIA Chemistry Lipase — Class II medical device recall Z-1363-2020
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2020-03-04, distributed nationwide. Firm has received customer complaints regarding failed calibrations and increased imprecision of quality contr
| Recall number | Z-1363-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2019-12-20 |
| Classified | 2020-02-26 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2020-12-21 |
| Distributed | Nationwide (US) |
| Quantity | 3,224 |
| UPC / GTIN / UDI-DI | 00630414482446 |
| Lot numbers | 485700 |
| Model numbers | 01984894, B01-4840-01 |
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 for recall
Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1363-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.