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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Chemistry Lipase

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  Class 2 Device Recall ADVIA Chemistry Lipase see related information
Date Initiated by Firm December 20, 2019
Date Posted January 30, 2020
Recall Status1 Terminated 3 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
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 2		 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.
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