China NMPA Product Recall - Abnormal Prothrombin Assay Kit (Immunofluorescence Assay)

Fujifilm Wako Pure Chemical Corporation, through its Shanghai subsidiary, Fujifilm Wako Pure Chemical (Shanghai) Co., Ltd., has initiated a voluntary Class II recall of its Abnormal Prothrombin Assay Kit (Immunofluorescence Method). This medical device, registered under National Medical Device Registration Certificate 20163402602, is subject to recall due to a critical performance issue. Specifically, certain batches demonstrated a tendency for higher measured values in the low concentration range as they neared their expiration date. This deviation could lead to clinically significant inaccuracies in diagnostic testing, potentially affecting patient treatment decisions based on prothrombin levels. The National Medical Products Administration (NMPA) oversees this recall action, ensuring regulatory compliance. While no specific inspection dates are noted, the company's proactive measure underscores its responsibility to product integrity. The required action involves the systematic retrieval of affected products, with comprehensive details on specific batches and further instructions provided in the "Medical Device Recall Event Report Form." This recall emphasizes the ongoing need for vigilance in medical device quality assurance to safeguard public health and maintain diagnostic reliability.