China NMPA Product Recall - Fully automated sample processing system

Thermo Fisher Scientific (Shanghai) Instruments Co., Ltd., as the registered agent for Thermo Fisher Scientific Oy's Fully Automated Sample Processing System (TCAutomation), initiated a Class III recall published by the National Medical Products Administration (NMPA) on December 7, 2016. The recall, reported on October 10, 2016, addresses a critical safety concern: the risk of generating incorrect sample test results if users do not diligently check all error messages issued by the instrument, as outlined in the product operation manual. Specifically, a "Cross Check Failure 'Main Module Name' error" could lead to erroneous data being provided to clinicians and patients. The affected products include 10 units manufactured, with 4 sold in China, and impacts regions globally. To mitigate immediate risks, Thermo Fisher Scientific and its importer, Werfen Medical Device Trading (Beijing) Co., Ltd., instructed customers to retest samples immediately when the instrument alarms, following a specific three-step procedure. The long-term resolution involves a mandatory software update to version 4.2. Werfen's after-sales service engineers are proactively performing on-site maintenance to implement this software upgrade, ensuring the system operates correctly and prevents the dissemination of inaccurate clinical data.