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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Chemistry Triglyceride_2 concentrated

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  Class 2 Device Recall ADVIA Chemistry Triglyceride_2 concentrated see related information
Date Initiated by Firm March 07, 2016
Create Date May 14, 2016
Recall Status1 Terminated 3 on December 01, 2017
Recall Number Z-1670-2016
Recall Event ID 73635
510(K)Number K133067  
Product Classification Lipase hydrolysis/glycerol kinase enzyme, triglycerides - Product Code CDT
Product ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575.

For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.
Code Information Kit lots 348297 & 359932.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Loriann Russo
914-524-2287
Manufacturer Reason
for Recall		 Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932.
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens mailed an Urgent Field Safety Notice, dated March 2016, to customers confirming the ADVIA Triglyceride concentrated reagent (TRIG_c) does not meet Instructions for Use (IFU) linearity claim at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932. Siemens asked customers to discontinue use of and discard kits from the two referenced lots, complete and return the Field Correction Effectiveness Check attached to the letter within 30 days. Customers were to review their inventory to determine their laboratory 's replacement needs. Customers are asked to retain the letter for their records and forward a copy to anyone that received the product. Customers may contact Siemens Customers Service or their local technical support.
Quantity in Commerce 7,433 units (4,228 for lot 348297 and 3,199 for lot # 359932)
Distribution Worldwide Distribution -- USA, including the states of CA, TN, UT, OK, FL, MI, MN, NY, CT, NC, KS, TX, CO, WA, NM, and OR; and, the countries of Austria, Australia, Belgium, Brazil, Bulgaria, Denmark, Estonia, France, Germany. Great Britain, Italy, Latvia, Netherland, Norway, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Czech Republic, India, New Zealand, Thailand, Turkey, and Russian Fed.
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.
510(K) Database 510(K)s with Product Code = CDT and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS, INC.
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