Class 2 Device Recall ADVIA Chemistry Lipase

• Date Initiated by Firm: December 20, 2019
• Date Posted: January 30, 2020
• Recall Status: Terminated on December 21, 2020
• Recall Number: Z-1363-2020
• Recall Event ID: 84768
• Product Classification: Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
• 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.
• Code Information: lot 485700
• FEI Number: 2432235
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 511 Benedict Ave; Tarrytown NY 10591-5005
• For Additional Information Contact: Mir Khan; 914-524-3074
• Manufacturer Reason for Recall: Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.