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U.S. Department of Health and Human Services

Class 2 Device Recall FlexLab (aka Accelerator a3600 and Aptio Automation)

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  Class 2 Device Recall FlexLab (aka Accelerator a3600 and Aptio Automation) see related information
Date Initiated by Firm April 07, 2020
Create Date May 26, 2020
Recall Status1 Completed
Recall Number Z-2114-2020
Recall Event ID 85537
510(K)Number K121012  
Product Classification Electrode, ion specific, potassium - Product Code CEM
Product FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: 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 systems consolidate multiple Analytical instruments into a unified workstation.
Code Information Serial Numbers: FLX.0133 FLX.0191 FLX.0192 FLX.0197 FLX.0198 FLX.0201 FLX.0202 FLX.027 FLX.0200 FLX.0181 
Recalling Firm/
Manufacturer		 Inpeco S.A.
Via San Gottardo 10
Lugano Switzerland
Manufacturer Reason
for Recall		 The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design.
FDA Determined
Cause 2		 Component design/selection
Action Urgent: Medical Device Correction notification letters dated 3/30/20 were sent to customers. Action to be taken by the user After module protection removal, wait at least 2 seconds before accessing the impacted module (listed in Table 1). Your service provider will contact you to replace the sensor. Until the service visit please maintain awareness on this notice. Please complete and return the "Customer Letter Receipt Confirmation and Implementation Check form" attached to this letter within 15 days directly to the email address specified in the email communication. Please transfer this notice to whom it might concern. Contact reference person: For any clarification you may need, do not hesitate to contact: Eva Balzarotti - Regulatory Affairs Manager E-mail: Regulatorv.Affairs@inpeco.com Phone: (+41) 919118 224
Quantity in Commerce 10 systems
Distribution The products were distributed to the following US States: IL and NY.
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.
510(K) Database 510(K)s with Product Code = CEM and Original Applicant = INPECO S.P.A.
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