China NMPA Product Recall - Anti-thyroid peroxidase antibody detection kit (electrochemiluminescence method)

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Antithyroid Peroxidase Antibody Detection Kit (Electrochemiluminescence Assay), as announced by the National Medical Products Administration (NMPA) on September 4, 2020. The recall stems from internal validation experiments revealing that the interference concentration of rheumatoid factor (RF) in the kit did not meet the specifications detailed in the current instructions for use. This issue specifically impacts products used on the cobas e411, cobas e601, and cobas e602 platforms. The company's required action involves updating the instructions for use to reflect accurate RF interference concentrations, with this change applying to all current and future product batches. The Antithyroid Peroxidase Antibody Detection Kit used on the cobas e801 platform remains unaffected. This action underscores the company's commitment to product safety and regulatory compliance under the NMPA's oversight.