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Terminated

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.

FDA Recall Z-2973-2020 · Posted None

Recalling FirmInpeco S.A.
Recall StatusTerminated
Product CodeCEM
Date Initiated2020-08-07
Date Terminated2021-12-02
Product Quantity2 US and 6 OUS

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

Firm 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: [email protected] Phone: (+41) 919118 224

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121012FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A. · 2012-08-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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