China NMPA Product Recall - Carbohydrate Antigen 72-4 Assay Kit (Electrochemiluminescence); Tumor Marker Control Samples

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for specific batches of its Carbohydrate Antigen 72-4 Assay Kit (Electrochemiluminescence) and Tumor Marker Control Product. This action, reported by the Shanghai Municipal Drug Administration and published by the National Medical Products Administration (NMPA) on March 9, 2020, was initiated due to customer feedback indicating a significant performance issue. Users reported that when employing the Carbohydrate Antigen 72-4 Assay Kit (batch number 408164) and the Tumor Marker Control Product (batch number 415249) with Level 2 quality control on the cobas 801 module, the obtained results consistently surpassed the +3 standard deviation limit. This deviation signifies a potential inaccuracy in the assay's performance and control product's reliability, which could affect diagnostic outcomes. The Level III classification indicates that while the product is violative, its use or exposure is not likely to cause adverse health consequences. As a required action, Roche Diagnostics is proactively recalling the affected batches of these medical devices (Registration Certificate Nos.: 20183402635, 20163404531). This measure ensures compliance with regulatory standards overseen by the NMPA and addresses the reported quality control excursions to safeguard the integrity and accuracy of diagnostic testing.