China NMPA Product Recall - Thyroglobulin Antibody Detection Kit (Electrochemiluminescence Method)

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall on August 28, 2019, concerning a specific batch of its Thyroglobulin Antibody Detection Kit (Electrochemiluminescence Imaging). This recall, reported under the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, addresses a performance issue identified during the company's routine internal quality control. The main issue, affecting batch number 40681601, involves a significant decrease in the calibration signal value, leading to low quality control recovery rates and results exceeding -3SD. Roche Diagnostics emphasized that this problem is detectable through good laboratory practices and routine quality control testing, and is not expected to affect patients or users. The required action is a voluntary recall of the affected batch of the Thyroglobulin Antibody Detection Kit to maintain product integrity and ensure compliance with regulatory standards, with other product batches remaining unaffected.