China NMPA Product Recall - Electrolyte analyzer

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its electrolyte analyzer on February 3, 2021, as reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall stems from an internal validation study revealing a display anomaly: when the calcium ion test unit was set to mg/dL and the measured value fell below the normal range, the arrow direction on the screen might incorrectly indicate the trend. Importantly, the actual numerical results displayed on the screen were accurate, and all printed output, including the arrow direction, was correct. This issue exclusively impacted the calcium ion test, and Roche had not received any customer complaints regarding the matter prior to the recall. The company's proactive measure ensures product integrity, with specific affected models and batches detailed in the associated Medical Device Recall Event Report Form. This voluntary action underscores adherence to regulatory standards for medical device safety.