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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Lipase Flex Reagent Cartridge

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  Class 2 Device Recall Dimension Lipase Flex Reagent Cartridge see related information
Date Initiated by Firm September 07, 2018
Create Date November 14, 2018
Recall Status1 Terminated 3 on November 16, 2020
Recall Number Z-0465-2019
Recall Event ID 81237
510(K)Number K952816  
Product Classification Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
Product Dimension Lipase Flex Reagent Cartridge, Model Number 10460277

Product Usage:
Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension¿ clinical chemistry system.
Code Information Lot Numbers: GD9002, GA9003, GB9032, GA9038
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
Newark DE 19702-2466
For Additional Information Contact Heydi Calderon
302-631-0522
Manufacturer Reason
for Recall		 There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Medical Device Correction letters dated 9/7/18 were distributed to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product.
Quantity in Commerce 18396
Distribution Worldwide - US Nationwide Distributions The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Brazil, Canada, Chile, China, Colombia, Germany, Ecuador, Honduras, Indonesia, India, Japan, Republic of Korea, Mexico, Malaysia, Nicaragua, New Zealand, Peru, Philippines, Paraguay, El Salvador, Thailand, Taiwan, Uruguay and South Africa, Austria, Bahamas, Belgium, Czech Republic, Denmark, , France, , Italy, Netherland, Norway , Portugal, Kuwait, Slovenia, Spain, Switzerland, United Kingdom, Qatar, Republic of Korea, Saudi Arabia, Slovakia, Algeria, Bahrain, Bulgaria, Egypt, , Hungary, Latvia, Lebanon, Lithuania, Macedonia, Nepal, Poland, Romania, Russia Fed, Serbia, Turkey, U.A.E, United Kingdom.
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 = CHI and Original Applicant = DUPONT MEDICAL PRODUCTS
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