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U.S. Department of Health and Human Services

Class 2 Device Recall FlexLab (with different names by distributors: Accelerator a3600 and Aptio Automation)

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  Class 2 Device Recall FlexLab (with different names by distributors: Accelerator a3600 and Aptio Automation) see related information
Date Initiated by Firm August 07, 2020
Create Date September 16, 2020
Recall Status1 Terminated 3 on December 02, 2021
Recall Number Z-2973-2020
Recall Event ID 86263
510(K)Number K121012  
Product Classification Electrode, ion specific, potassium - Product Code CEM
Product FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and
Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.
Code Information Serial Numbers: US: FLX.0133 FLX.0181  OUS: FLX.0048 FLX.0049 FLX.0121 FLX.0155 FLX.0160 FLX.0200 
Recalling Firm/
Manufacturer		 Inpeco S.A.
Via San Gottardo 10
Lugano Switzerland
Manufacturer Reason
for Recall		 Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
FDA Determined
Cause 2		 Software design
Action Inpeco issued Customer Letter dated August 7, 2020 forwarded to the customers either by Inpeco (for the laboratories where Inpeco is directly the distributor) or by the Inpeco distributors. Letter states reason for recall, health risk and action to take: customers impacted by the Field Action have to complete and return the Recall Letter Receipt Confirmation and Implementation Check form attached to the Customer letter within 15 days to Inpeco or the distributor. The customers impacted by the issue will be contacted by Inpeco or the distributors to arrange a visit to upgrade the impacted modules firmware. Contact reference person: Eva Balzarotti - Regulatory Affairs Manager. E-mail: Regulatory.Affairs@inpeco.com Phone: (+41) 919118 224
Quantity in Commerce 2 US and 6 OUS
Distribution Worldwide distribution - US Nationwide distribution including in the states of AK, FL, IA, LA, MA, MS, MT, NC, OH, TX, VA and the countries of AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, NETHERLANDS. NORWAY SAUDI ARABIA SOUTH KOREA SWEDEN UNITED ARAB EMIRATES
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 = CEM and Original Applicant = INPECO S.P.A.
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