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

Roche Diagnostics GmbH initiated a voluntary global recall of specific electrode kits for blood gas, electrolyte, and biochemical analyzers, distributed in China by Roche Diagnostics Products (Shanghai) Co., Ltd. The recall was prompted by internal testing revealing that certain batches, such as Lot No. 21560881, incorrectly measure Na+ concentration in whole blood samples due to interference from the partial pressure of CO2. This issue affects products used with Roche cobas b 123 system series analyzers. The recall report was filed with the National Medical Products Administration (NMPA) on June 24, 2016, and the NMPA published the alert on July 11, 2016. Despite the global scope of the recall, Roche Diagnostics Products (Shanghai) Co., Ltd. confirmed that none of the affected products were imported into or sold within China. Therefore, no direct corrective actions, such as product retrieval or rework, were necessary within the Chinese market. The NMPA, however, mandated that provincial Food and Drug Administrations strengthen their supervision and management of similar diagnostic products to ensure ongoing public safety. No serious patient adverse events related to this issue have been reported globally.