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

On April 12, 2019, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Roche Diagnostics Products (Shanghai) Co., Ltd. The recall pertains to their Direct Bilirubin Detection Kit (Diazo Method), identified under Registration Certificate No. 20142405074. This action was taken by the company following customer reports of significant performance anomalies. Specifically, users experienced low quality control recovery rates during testing immediately after opening the product, and encountered calibration failures when utilizing the kit. This issue impacts the diagnostic accuracy and reliability of the medical device. Operating within the regulatory framework of the NMPA and referencing a Shanghai Food and Drug Administration Medical Device Registration Certificate, Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily removing the affected kits from distribution. The required action involves the recall of specific models, specifications, and batches of the product, with detailed information made available in an accompanying Medical Device Recall Report Form. This measure aims to address the product quality concerns and ensure the integrity of diagnostic results.