# China NMPA Product Recall - LIAISON® 25-OH Vitamin D Total Assay Kit (Chemiluminescent Immunoassay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/diasorin-inc/b930fd25-63cf-42a8-9507-e83b106adc76/
Source feed: China

> China NMPA product recall for LIAISON® 25-OH Vitamin D Total Assay Kit (Chemiluminescent Immunoassay) by DiaSorin Inc. published January 13, 2023. Recall level: Level 3 Recall. DiaSorin Inc., in conjunction with its subsidiary, DiaSorin Medical Devices (Shanghai) Co., Ltd., ha

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: DiaSorin Inc. (USA) is issuing a voluntary recall for its LIAISON® 25OH Vitamin D TOTAL Assay kit (chemiluminescent immunoassay).
- Company Name: DiaSorin Inc.
- Publication Date: 2023-01-13
- Product Name: LIAISON® 25-OH Vitamin D Total Assay Kit (Chemiluminescent Immunoassay)
- Recall Level: Level 3 Recall
- Recall Reason: The problem of magnetic particles not being able to mix properly
- Discovering Company: Soling Diagnostics Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: DiaSorin Inc.
- Summary: DiaSorin Inc., in conjunction with its subsidiary, DiaSorin Medical Devices (Shanghai) Co., Ltd., has initiated a voluntary Class III recall for specific models and batches of its LIAISON® 25 OH Vitamin D TOTAL Assay Kit (Chemiluminescent Immunoassay). This significant action, publicly reported by the National Medical Products Administration (NMPA) on January 13, 2023, stems from a manufacturing issue. The core problem identified is the potential for magnetic particles within the assay kit to not mix properly. This defect could compromise the accuracy and reliability of test results, which are vital for correctly assessing a patient's total vitamin D levels. The LIAISON® 25 OH Vitamin D TOTAL Assay, identified by Registration Certificate No.: 20192400417, is a widely used diagnostic tool. The decision to implement a Class III recall signifies that while the product is violative, its use or exposure is not expected to cause adverse health consequences. However, ensuring the integrity of diagnostic tests is paramount for effective patient care. Detailed information, including the specific models, specifications, and batch numbers implicated in this recall, is provided in the accompanying "Medical Device Recall Event Report Form." This proactive recall by DiaSorin underscores its commitment to product quality and compliance with regulatory standards set by the NMPA, safeguarding public health in the diagnostic sector.

Company: https://www.globalkeysolutions.net/companies/diasorin-inc/a8746bb1-3f9d-42f9-88bd-bfa4aecf5bda/