ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 006304...
FDA Recall #Z-1363-2020 — Class II — December 20, 2019
Product Description
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.
Recalling Firm
Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3224
Distribution
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.
Code Information
lot 485700
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated