China NMPA Product Recall - Direct bilirubin assay kit (diazo method)

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Direct Bilirubin Detection Kit (Diazo Method). This action, published by the National Medical Products Administration (NMPA) on August 20, 2019, and updated by the Shanghai Food and Drug Administration, followed multiple customer complaints. The primary issues identified were low quality control recovery rates or calibration failures when using specific batches of the kit, namely 33798101 and 35714101, on the cobas c 701/702 diagnostic platform. Roche Diagnostics headquarters confirmed these performance deficiencies, leading to the expansion of the affected batch list. The voluntary recall signifies a proactive measure by the company to address product quality concerns and ensure patient safety. This action is undertaken within the regulatory framework overseen by the NMPA, which mandates manufacturers to address and report issues with medical devices. Detailed information regarding the affected product models and specifications is available in the associated "Medical Device Recall Event Report Form," indicating the company's compliance with regulatory reporting requirements.