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

Source: https://www.globalkeysolutions.net/records/china_product_recall/fujifilm-wako-pure-chemical-corporation/a589dab1-5074-43be-ad8d-549129b5d4dd/
Source feed: China

> China NMPA product recall for Abnormal Prothrombin Assay Kit (Immunofluorescence Assay) µTASWako PIVKAII by FUJIFILM Wako Pure Chemical Corporation published February 21, 2025. Recall level: Level 2 Recall. Fujifilm Wako Pure Chemical Corporation has initiated a voluntary Class II recall for its Abnormal P

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## 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: 2025-02-21
- Product Name: Abnormal Prothrombin Assay Kit (Immunofluorescence Assay) µTASWako PIVKAII
- Recall Level: Level 2 Recall
- Recall Reason: For specific batches of products, the measured values in samples from low-concentration areas 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 has initiated a voluntary Class II recall for its Abnormal Prothrombin Assay Kit (Immunofluorescence Method) µTASWako PIVKAII. This action was taken after Fujifilm Wako Pure Chemical (Shanghai) Co., Ltd. reported a significant issue: certain batches of the assay kit demonstrated a tendency to produce higher measured values when processing low-concentration samples. This critical defect could lead to inaccurate diagnostic results, potentially impacting patient care and clinical decisions related to prothrombin assessment. The affected product carries National Medical Device Registration Certificate 20163402602.

The recall is being conducted under the regulatory guidance and oversight of the National Medical Products Administration (NMPA). A Class II recall level indicates that the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Fujifilm Wako Pure Chemical Corporation is taking comprehensive steps to remove all affected units from distribution and prevent further use, ensuring compliance with medical device safety standards and mitigating potential risks to public health.

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