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Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usag
Recalled March 4, 2020 · FDA recall Z-1363-2020 · Siemens Healthcare Diagnostics
Hazard
Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product. · FDA Class II
Units
3224
Sold at
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CT, FL, GA, IA, KS, MD, MI, NJ, NM, NY, OH, OK, PA, TN, TX, WA.
Description
Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →