China NMPA Product Recall - Prothrombin Time Test Card (Electrochemical Method)

Roche Diagnostics GmbH, via its subsidiary Roche Diagnostics Products (Shanghai) Co., Ltd., initiated a voluntary Class II recall of its Prothrombin Time Test Cards (Electrochemical Method). This recall, announced by the National Medical Products Administration (NMPA) on October 17, 2024, stems from the discovery that the test cards produced "%Quick values exceeding product specifications," specifically yielding false low readings. This deviation posed a potential concern for diagnostic accuracy. The affected product, registered under National Medical Device Registration Certificate No. 20202400275, was voluntarily recalled by the manufacturer to address this quality issue. Crucially, the specific batches identified in this recall were not imported into the Chinese market, thereby localizing the impact of the issue. A Class II recall, as designated by regulatory bodies, indicates a situation where the use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Detailed information regarding the involved models, specifications, and batch numbers is available in the official "Medical Device Notice" and accompanying "Medical Device Recall Event Report Form." This proactive measure underscores the company's commitment to product safety and quality assurance.