China NMPA Product Recall - tissue processing machine

Thermo Fisher Scientific (China) Co., Ltd. initiated a voluntary Class III recall of its Excelsior AS Tissue Processor, reported to the National Medical Products Administration (NMPA) on March 3, 2016. The recall stems from a discovered software error where, approximately 248 days after initial power-on, the device's internal counting cycle could invert from positive to negative. This critical flaw causes the rotary valve to cease movement mid-cycle, potentially leading to inadequate pathological sample processing. While the issue triggers audible and visual alarms, and poor processing results can be detected in subsequent laboratory steps, it primarily causes inconvenience and short-term delays in clinical diagnostics, without posing a direct risk of misdiagnosis or patient harm. Thermo Fisher Scientific has outlined immediate and long-term corrective actions. Temporarily, operators can restart affected devices using a 10-step procedure upon an alarm. The definitive solution involves a software upgrade to version 2548 - Issue 16, which the company's after-sales service engineers are proactively installing on-site for all 82 affected units distributed in China. This proactive measure ensures product safety and reliability.