medical Class II Updated 2020-03-04

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siem

Recalled 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.

Hazard / Issue

Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: lot 485700
View official government recall

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