China NMPA Product Recall - Buffer solution MagNA Pure 96 System Fluid (Internal Container); Buffer solution MagNA Pure 96 System Fluid (External)

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall on June 2, 2020, for specific batches of its MagNA Pure 96 System Fluid (Internal Container) and MagNA Pure 96 System Fluid (External) buffers. The recall, reported by the Shanghai Municipal Drug Administration and overseen by the National Medical Products Administration (NMPA), addresses a labeling inaccuracy. The primary issue was an incorrect production date printed on the English label of product packaging for some batches. This error occurred because the company expedited production to meet increased demand during the global COVID-19 pandemic, resulting in batches being completed ahead of schedule and preventing readjustment of pre-printed English labels. Crucially, the expiration dates on all labels, along with the production dates on the Chinese labels and certificates of conformity, were accurate. Roche Diagnostics confirmed that the performance of the affected products is not compromised, and there is no impact on diagnostic results or patient safety. The company ruled out medical risks to patients and users. The required action is a voluntary recall of the identified products (Registration Certificate Nos.: 20152006 and 20152007) to correct the labeling inconsistency, even though no functional or safety defects are present.