China NMPA Product Recall - D-dimer detection card (colloidal gold method)

On May 13, 2019, the National Medical Products Administration (NMPA) announced a voluntary product recall initiated by Roche Diagnostics Products (Shanghai) Co., Ltd. The affected product is the D-Dimer Detection Cards (Colloidal Gold Method), identified by Registration Certificate No. 20182401596. The recall stems from an identified labeling discrepancy: an error in the production date printed on the labels of a specific batch of these detection cards.

Roche Diagnostics proactively initiated this recall to address the labeling issue. The company determined that the incorrect production date constituted a product defect requiring corrective action. Consequently, the recall has been classified as Class III, indicating that while the issue is not likely to cause serious adverse health consequences, it warrants removal or correction of the affected product.

This action highlights the regulatory oversight of the NMPA, which hosts the official announcement, ensuring transparency and public awareness of medical device safety issues within China. Roche Diagnostics Products (Shanghai) Co., Ltd. is required to provide detailed information regarding the affected models, specifications, and batch numbers in a Medical Device Recall Event Report Form, which is accessible via the NMPA website. This voluntary recall underscores the company's commitment to product quality and patient safety, aligning with national medical device regulations.