China NMPA Product Recall - Electrode boxes for blood gas, electrolyte and biochemical analyzers

The National Medical Products Administration (NMPA) announced a voluntary recall by Roche Diagnostics GmbH, initiated on December 10, 2015, regarding specific electrode kits for blood gas, electrolyte, and biochemical analyzers. The distributor, Roche Diagnostics Products (Shanghai) Co., Ltd., reported this action. The core issue, identified through internal testing, revealed that the detection of sodium (Na+) concentration in whole blood samples could be inaccurately influenced by the partial pressure of carbon dioxide (CO₂) when using certain batches of these electrode cartridges with the Roche cobas b 123 system. Despite the recall, Roche Diagnostics confirmed that none of the affected products were sold within the Chinese market. The NMPA, operating under China's regulatory framework for medical devices, requested provincial drug administrations to strengthen their supervision and management of similar products. Importantly, Roche Diagnostics has not received any reports of serious adverse patient events globally related to this issue. Consequently, as no affected units were distributed or sold in China, no direct corrective actions are required for Chinese end-users or healthcare facilities regarding product returns or replacements.