China NMPA Product Recall - ADVIA 2120/2120i Blood Analyzer

Siemens Medical Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its ADVIA 2120/2120i blood analyzers. This action, reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on March 10, 2021, and April 22, 2021, respectively, addresses a critical issue identified in devices operating with system software versions 6.10 and 6.11. The primary concern involves the analyzers' inability to accurately interpret 14-digit Sample ID (SID) barcodes that contain non-alphanumeric characters. This misreading capability poses a significant risk to patient sample identification and could lead to incorrect diagnostic results or treatment decisions. As a proactive measure, Siemens Healthcare Diagnostics Inc. voluntarily recalled affected units (Registration Certificate Nos.: CFDA (Imported) 2013 No. 2402588; CFDA Import Registration No. 20162404708). The company provided detailed information regarding the specific product models, specifications, and batch numbers in a 'Medical Device Recall Event Report Form'. This voluntary recall underscores the manufacturer's responsibility under the NMPA's regulatory oversight to ensure the safety and reliability of medical devices. Users of these analyzers should consult the provided recall information for necessary actions.