China NMPA Product Recall - Washing solution, diluent

On July 14, 2017, the National Medical Products Administration (NMPA) publicized a voluntary Class III product recall initiated by Bio-Rad Medical Products (Shanghai) Co., Ltd. This recall specifically concerned batches of their washing solution and diluent, which carried the registration number CFDA (Imported) 1400605. The critical issue identified by the company was significant errors present on the Chinese labels of these medical devices. Bio-Rad Medical Products (Shanghai) Co., Ltd. took proactive steps to report this labeling discrepancy to the NMPA and subsequently commenced the recall process for the affected products. This action highlights the company's dedication to maintaining product quality, ensuring accurate information for consumers, and adhering to the stringent regulatory requirements overseen by the NMPA. The Class III classification for this recall indicates that while the labeling error was significant, it was unlikely to cause serious adverse health consequences. Detailed information pertaining to the specific models, specifications, and batch numbers of the involved products was provided in the official "Medical Device Recall Event Report Form" attachment, outlining the precise scope of this corrective measure. The recall served to rectify the labeling inaccuracies, upholding the integrity of information provided for medical devices circulated within the Chinese market.