China NMPA Product Recall - Albumin-Total Protein Complex Assay Kit (Dry Chemical Colorimetric Method) VITROS XT Chemistry Products ALB-TP Slides

The National Medical Products Administration (NMPA) announced on July 16, 2024, a Level II voluntary recall initiated by Ortho-Clinical Diagnostics, Inc. for its Albumin-Total Protein Composite Assay Kit. Specifically, the recall targets the VITROS XT Chemistry Products ALB-TP Slides, registered under National Medical Device Registration No. 20222400118. The primary concern leading to this recall stems from identified issues with the assay kit that have the potential to adversely affect test results, thereby raising patient safety and diagnostic accuracy concerns. Under the regulatory oversight of the NMPA, the manufacturer is undertaking this voluntary action to mitigate potential risks associated with the defective product. While the specific models, specifications, and batch numbers are detailed in an attached Medical Device Recall Event Report Form, the document clarifies that the products involved in this particular recall were not imported into China. The required action is a manufacturer-initiated voluntary recall, demonstrating the company's compliance with NMPA guidelines for addressing product deficiencies that could impact public health.