China NMPA Product Recall - Testosterone Assay Kit (Chemiluminescence Method) Access Testosterone

Beckman Coulter, Inc. has initiated a voluntary Class II recall concerning its Testosterone Assay Kit (Chemiluminescence Method), as reported to the National Medical Products Administration (NMPA) by Beckman Coulter Trading (China) Co., Ltd. on May 19, 2025. The core issue precipitating this action is the discovery of cross-contamination during the manufacturing process affecting certain batches of the assay kit. This manufacturing defect prompted Beckman Coulter, Inc. to undertake a corrective measure to uphold product quality standards and safeguard diagnostic accuracy. The regulatory oversight for this recall falls under the purview of the NMPA in China, evidenced by the product's National Medical Device Registration Certificate No. 20152403870. A significant aspect of this recall is the confirmation that despite being reported through the Chinese regulatory framework, the specific product batches subject to this recall were not distributed or imported into the Chinese market. This voluntary action demonstrates the company's commitment to promptly addressing quality concerns. Specific details regarding the affected models, specifications, and batch numbers are available in the comprehensive Medical Device Recall Event Report Form provided by the company.