China NMPA Product Recall - Blood gas, electrolyte, and biochemical calibrators

Roche Diagnostics Products (Shanghai) Co., Ltd., representing its German manufacturer Roche Diagnostics GmbH, initiated a voluntary Class II recall of specific batches of its Blood Gas, Electrolyte, and Biochemical Multiple Calibrators. This action was reported to the National Medical Products Administration (NMPA) on July 28, 2016, and publicly announced on September 30, 2016. The primary issue identified was a potential calibration error affecting the oxygen partial pressure (pO2) parameter. Investigations revealed that using calibrators from certain batch numbers (e.g., 21456184, 21456134-21456383) could lead to inaccurately low pO2 test results, particularly when blood sample pO2 values are below 50 mmHg. While global complaints were received regarding lower-than-expected pO2 quality control results, no related patient complaints or adverse events due to low pO2 levels were reported in China or elsewhere. Under the NMPA's regulatory framework, Roche Diagnostics is undertaking corrective actions. These include promptly notifying all users via a formal letter about the identified issue. Crucially, the company has instructed users to discontinue using the affected calibrators for pO2 parameter testing to prevent erroneous patient results. This recall is proactive and focuses on preventing potential diagnostic inaccuracies, though it does not involve the physical withdrawal of the affected product batches from circulation.