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

Source: https://www.globalkeysolutions.net/records/china_product_recall/fujifilm-wako-pure-chemical-corporation/72971012-4e3d-4927-8b4a-d5115c1998ed/
Source feed: China

> China NMPA product recall for Abnormal Prothrombin Assay Kit (Immunofluorescence Assay) by FUJIFILM Wako Pure Chemical Corporation published May 29, 2025. Recall level: Level 2 Recall. Fujifilm Wako Pure Chemical Corporation, through its Shanghai subsidiary, Fujifilm Wako Pure Chemica

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Fujifilm Wako Pure Chemical Corporation is voluntarily recalling its Abnormal Prothrombin Assay Kit (Immunofluorescence Assay).
- Company Name: FUJIFILM Wako Pure Chemical Corporation
- Publication Date: 2025-05-29
- Product Name: Abnormal Prothrombin Assay Kit (Immunofluorescence Assay)
- Recall Level: Level 2 Recall
- Recall Reason: For specific batches of products nearing the end of their expiration date, the measured values in the low concentration range tend to be higher.
- Discovering Company: Fujifilm and Guangchunyao (Shanghai) Chemical Co., Ltd.
- Manufacturing Company: FUJIFILM Wako Pure Chemical Corporation
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/fujifilm-wako-pure-chemical-corporation/67a75abd-70e5-46a0-b870-a0878f3e03db/