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

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a Class III voluntary recall for its Substrate Solution for Automated Immunoassay Systems (Medical Device Registration No. 20160545). This action, reported to the National Medical Products Administration (NMPA) on June 6, 2017, and publicly announced on July 19, 2017, addresses a critical labeling error. The recall specifically impacts batch number 940853, encompassing 5000 test kits distributed across China. The core issue stemmed from an incorrect production date printed on the product labels. The labels erroneously displayed December 8, 2015, when the correct production date was December 8, 2016. This inaccuracy also required subsequent modifications to the product's registration information within both the label and the instruction manual to ensure full regulatory compliance. Under the NMPA's regulatory guidance, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is undertaking a series of corrective measures. These include the immediate notification of all affected customers, the replacement of all implicated products, and the reporting of both company inventory and the recalled items to the relevant bureau for supervised destruction. These steps are designed to rectify the labeling discrepancy and maintain product integrity within the medical device supply chain.