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

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall on August 4, 2015, concerning multiple batches of their Blood Gas, Electrolyte, and Biochemical Multiple Calibrators, manufactured by Roche Diagnostics GmbH (Germany). The recall was prompted by user feedback indicating failures in oxygen partial pressure (PO2) quality control testing when using these calibrators with the cobas b123 POC fully automated analyzer. Investigation revealed that an excessive amount of oxygen within the calibration solution was the root cause, leading to potentially inaccurate, lower-than-expected PO2 readings. This defect could result in patients receiving unnecessary oxygen due to misdiagnosed low PO2 levels. The affected products include various cobas b123 Fluid Pack COOX and Fluid Pack models. Under the oversight of the National Medical Products Administration (NMPA), Roche Diagnostics implemented several corrective actions. These included informing customers via notification letters about the incident and necessary steps. Users of the affected calibrator batches were specifically instructed to set the PO2 parameter to "elimination activation" on their analyzers to mitigate the risk of reporting falsely low PO2 results. This proactive measure aims to ensure patient safety and data accuracy.