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

Beckman Coulter, Inc., through its Chinese affiliate Beckman Coulter Trading (China) Co., Ltd., announced a voluntary recall concerning its Thyroglobulin Antibody Assay Kit (Access Thyroglobulin Antibody II). This recall, reported on September 18, 2024, by the National Medical Products Administration (NMPA), addresses a critical error in the product's English instructions for use. Specifically, the biotin interference statement was inadvertently deleted, which could potentially lead to inaccurate test results if users are unaware of possible interference from biotin. The affected product is a chemiluminescence method assay kit with National Medical Device Registration Certificate No. 20162404041. While the manufacturer, Beckman Coulter, Inc., initiated this voluntary recall due to the omitted safety information, the report explicitly clarifies that none of the products involved in this specific recall event were imported into China. Therefore, while the NMPA is publishing this information for transparency and oversight within its regulatory framework, direct actions for products currently in the Chinese market related to this particular recall are not necessary. This notification serves to inform stakeholders about the manufacturer's corrective action regarding a potential safety information omission.