China NMPA Product Recall - Substrate solutions for fully automated immunoassay systems

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Substrate Solution for Automated Immunoassay Systems (Medical Device Registration No. 20160545), as reported on July 18, 2017. The recall stemmed from a critical labeling error on product batch 940853, impacting 2000 units in China. The labels incorrectly displayed the production date as December 8, 2015, instead of the correct date, December 8, 2016. This discrepancy also necessitated corresponding updates to the product's registration information within the label and instruction manual. Under the regulatory oversight of the National Medical Products Administration (NMPA), the company implemented several corrective actions. Siemens was required to promptly inform all affected customers through formal letters. Furthermore, the company committed to replacing all identified affected products. All recalled units, along with existing company inventory of the erroneous batch, were slated for supervised destruction in coordination with the regulatory authorities. This recall highlights the importance of precise labeling and adherence to product registration details within the medical device industry.