China NMPA Product Recall - Fully automated chemiluminescence analyzer

Nanjing Renmai Biotechnology Co., Ltd. initiated a voluntary Class 3 medical device recall, formally reported on January 19, 2022, and published by the National Medical Products Administration (NMPA) on January 20, 2022. The recall pertains to 88 units of its Fully Automated Chemiluminescence Meter (model MCL60). The primary issue stemmed from an employee operational error during labeling. The product label incorrectly displayed "Fully Automated Chemiluminescence Analyzer" instead of the registered name, "Fully Automated Chemiluminescence Meter," creating an inconsistency with the official registration certificate (Su Medical Device Registration Certificate 20192220337). The company clarified that this labeling discrepancy does not impact the product's performance, test results, or patient safety, indicating no potential for harm. Under the guidance of the provincial drug administration, Nanjing Renmai Biotechnology Co., Ltd. took immediate corrective actions. These included issuing formal recall notices to all affected distributors, who were then mandated to inform their respective customers. Furthermore, the company implemented a direct label correction process for all 88 affected units, encompassing 84 units held in distributor inventory and 4 units already at end-customer sites. This swift response ensured compliance with regulatory requirements and addressed the labeling error effectively.