China NMPA Product Recall - Sample diluent VITROS Chemistry Products Specialty Diluent

The National Medical Products Administration (NMPA) has announced a voluntary Class II recall initiated by Ortho-Clinical Diagnostics, Inc., in conjunction with its Chinese affiliate, Ortho-Clinical Medical Devices Trading (China) Co., Ltd. This action, published on June 19, 2024, addresses concerns regarding certain batches of the company's VITROS Chemistry Products Specialty Diluent (National Medical Device Registration No. 20160802).

The primary reason for this corrective measure is the potential for these specific sample diluent batches to yield abnormal test results, which could compromise diagnostic accuracy. As a responsible step to ensure product reliability and patient safety, the manufacturer proactively initiated the recall. A Class II recall indicates a situation where use or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Details regarding the exact models, specifications, and affected batches are available in the accompanying "Medical Device Recall Event Report Form" provided by the NMPA. This initiative underscores the commitment to quality within the regulatory oversight of the NMPA.