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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Chemistry Systems Lipase

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  Class 2 Device Recall ADVIA Chemistry Systems Lipase see related information
Date Initiated by Firm March 23, 2015
Date Posted April 20, 2015
Recall Status1 Terminated 3 on December 18, 2015
Recall Number Z-1457-2015
Recall Event ID 70835
Product Classification Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
Product ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Code Information Catalog Number: B01-4840-01; Material Number (SMN)10311896, Lot Numbers: 318706, 332463, expiration dates 2015-06-30, 2015-08-31    
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Customer Support
312-275-7795
Manufacturer Reason
for Recall		 Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated ADVIA Chemistry Lipase outlier results when running with Triglycerides, Triglycerides_2, Triglycerides_c, Cholesterol concentrated, and DLDL reagents.
FDA Determined
Cause 2		 Device Design
Action Siemens issued an Urgent Medical Device Correction on March 23, 2015, notifying direct consignees about the product, problem, and action to be taken. Customers were instructed to follow the directions provided in the customer letter in the event that a Lipase outlier is observed. All customers were requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within (30) days. Field service personnel have been sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. For further questions please call (312) 275-7795.
Quantity in Commerce 7814
Distribution Worldwide Distribution - US (nationwide) Distribution and to the countries of : Thailand, Pakistan, Vatican, Guadeloupe, Reunion, French Polynesia , Serbia, Martinique, India, China, Singapore, Brazil, South Africa, Mexico, Canada, Israel, Australia, Egypt, Russian Federation, Indonesia, Rep. Korea (S) ,Unit.Arab Emir., Taiwan ,Argentina ,Chile, Malaysia ,Colombia, Peru, Kazakhstan, Paraguay, Vietnam, Algeria, Austria, Belgium, Switzerland, Cyprus, Czech Republic, Germany, Estonia, Spain, Finland, France, United Kingdom, Greece, Hungary, Italy, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovakia and Turkey.
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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