China NMPA Product Recall - Fully Automated Sample Processing System; Aptio Automation

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Fully Automated Sample Handling System (Aptio Automation) on October 11, 2021. This action was publicly reported by the Shanghai Municipal Drug Administration, operating under the regulatory framework of the National Medical Products Administration (NMPA). The recall addresses a critical firmware issue discovered in the ADVIA Centaur XP/XPT interface module of the Aptio Automation product. Under specific and occasional circumstances, this defect could lead to an incorrect association between test results and sample IDs, posing a risk to diagnostic accuracy. The recall encompasses particular affected product models, specifications, and batches, with detailed information available in the "Medical Device Recall Event Report Form." This proactive measure, undertaken in collaboration with Inpeco S.A. and Siemens Healthcare Diagnostics, Inc., aims to rectify the identified product deficiency and uphold patient safety and data integrity.