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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Chemistry Creatine Kinase (CK_L)

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  Class 2 Device Recall ADVIA Chemistry Creatine Kinase (CK_L) see related information
Date Initiated by Firm May 03, 2019
Create Date July 02, 2019
Recall Status1 Terminated 3 on January 19, 2021
Recall Number Z-1913-2019
Recall Event ID 82980
510(K)Number K160724  
Product Classification Nad reduction/nadh oxidation, cpk or isoenzymes - Product Code CGS
Product ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.
Code Information Serial Numbers: 465336,465663,468449
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
Newark DE 19702-2466
For Additional Information Contact
800-441-9250
Manufacturer Reason
for Recall		 A steady upward trend in blank (u) absorbance was observed
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens Healthineers issued Urgent Medical Device Recall notices to domestic customers and Urgent Field Safety Notices to international customers dated May 8, 2019. Actions to be Taken by the Customer 1) Discontinue use of and discard the kit lots listed on the notice. 2) Review your inventory of these products to determine your laboratorys replacement needs and provide information to Siemens for reporting to the authorities. 3) Complete and return the Field Correction Effectiveness Check letter within 30 days. 4) Please review the letter with your Medical Director. 5) If you have received any complaints of illness or adverse events associated with the products listed in the notice, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. 6) Please retain the letter with your laboratory records and forward the letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in Commerce 3,386
Distribution Worldwide distribution.
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 = CGS and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS, INC.
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