Recall – Lab automation system may misassociate sample IDs

Company: Inpeco S.A.
Date of Enforcement Report: 9/23/2020
Class II

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.

Recall Number: Z-2973-2020

REASON

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

RECALLING FIRM/MANUFACTURER

Inpeco S.A. on 8/7/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

2 US and 6 OUS

DISTRIBUTION

U.S. Nationwide and International

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Partners located in the US (CA, FL, MA, MN) and Italy.