FDA-Device2020-03-04Class II
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.
Siemens Healthcare Diagnostics, Inc.
Hazard
Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
Sold states
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.
Affected count
3224
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1363-2020Don't want to check this manually?
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