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U.S. Department of Health and Human Services

Class 2 Device Recall Sysmex XN Series Automated Hematology Analyzers

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  Class 2 Device Recall Sysmex XN Series Automated Hematology Analyzers see related information
Date Initiated by Firm March 23, 2017
Date Posted April 14, 2017
Recall Status1 Terminated 3 on August 22, 2019
Recall Number Z-2034-2017
Recall Event ID 76828
510(K)Number K112605  K141681  
Product Classification Counter, differential cell - Product Code GKZ
Product Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
Code Information **Model: XN-10, Product Number: AP795756, Serial Numbers: 11001  29656, 29668-29786, 29788-29798, 29800-29801, 29803, 29804, 29807, 29812, 29816-29867  **Model: XN-11, Product Number: CS297931, Serial Numbers: A1001-A1124, A1127, A1130, A1135-A1140, A1142-A1144, A1146-A1149, A1151, A1153-A1159, A1161, A1163, A1171
Recalling Firm/
Manufacturer		 Sysmex America Inc
577 Aptakisic Rd
Lincolnshire IL 60069-4325
For Additional Information Contact Sysmex Technical Assistance Center
888-879-7639
Manufacturer Reason
for Recall		 Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. Build-up of salt deposits on unprotected electronic components may combust due to heat generated by electronics when instrument cycles. Completed CAPA identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of the electronic protective shield during manufacturing of the device.
FDA Determined
Cause 2		 Component design/selection
Action Sysmex sent an Field Correction letter dated April 2017. Product will not be returned, but corrected at the customer site. The correction requires a service visit that will be documented in the Sysmex service Customer Relationship Management (CRM) software. The service report is accepted by the customer at the time of service. Completion of the service records will be tracked by reports generated from the Service CRM. For further Technical Assistance or questions please call (1 888) 879-7639.
Quantity in Commerce 3,682 units
Distribution Nationwide, Canada
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 = GKZ and Original Applicant = SYSMEX AMERICA, INC.
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