Siemens Healthcare Diagnostics, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
lot 485700
Products Sold
lot 485700
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 006304144 due to Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
Recommended Action
Per FDA guidance
On December 20, 2019, the recalling firm distributed Urgent Medical Device Recall letters to affected customers. Customers were provided with instructions for determining whether the Lipase reagent cartons in their inventory were impacted. The next reagent lot is expected to be available by February 2020. Customers were asked to review the letter with their Medical Director, review their inventory for affected products, and assess their laboratory's replacement needs as applicable. A customer response form was included with the recall communication so that customers may confirm that they have received the notification as well as report the quantity of replacement product required.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026