China NMPA Product Recall - Thyroglobulin Assay Kit (Chemiluminescence Method)

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall for specific batches of its Thyroglobulin Assay Kits (Item Number 33860) on September 7, 2015. This action, reported to the National Medical Products Administration (NMPA) in China, addressed a critical product issue. The company determined that certain reagent batches, specifically 430969, 431990, 434727, 522896, and 523251, exhibited a precision exceeding 10% when the detection concentration was below 10 ng/mL. This defect could lead to falsely elevated results in quantitative determinations of thyroglobulin levels, potentially impacting patient diagnoses when utilizing the Access Immunoassay System. The regulatory framework for this recall is established by the NMPA, referencing the product's CFDA Registration Certificate No. 2012 No. 2403524. In response, Beckman Coulter implemented several corrective actions globally. The company ceased all shipments of the affected products and proactively notified customers to discontinue their use. Furthermore, required actions included recalling all affected units—totaling 4150 units sold in China—and providing appropriate compensation to customers. This voluntary recall aims to mitigate risks associated with inaccurate diagnostic results and ensure product safety and reliability.