China NMPA Product Recall - Fully automated biochemical analyzer

The National Medical Products Administration (NMPA) published a recall report on July 21, 2010, regarding components of the Fully Automated Biochemical Analyzer manufactured by Siemens Healthcare Diagnostic Inc. and Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. This report documents a global recall initiated by Siemens Medical Diagnostics on March 16, 2010.

The core issue identified through an internal investigation was that certain chloride electrodes, specifically batch number 0904, used in the Adiva chemistry system (including models Adiva 1200, 1800, 2400, and 1650), had the potential to cause elevated test results. Despite this potential issue, a harm assessment confirmed no direct harm to patients.

Under the NMPA's regulatory framework, Siemens Medical Diagnostics (Wanghai) Co., Ltd. conducted a thorough verification for the Chinese market. They confirmed that no batches of the affected chloride electrodes were in circulation within China. As a result, no specific domestic corrective actions were required or implemented beyond this verification, as the affected products were not present in the Chinese supply chain. This NMPA report officially records the manufacturer's global recall and the confirmed status of these products in China.