# China NMPA Product Recall - Progesterone Assay Kit (Chemiluminescent Immunoassay) LIAISON® Progesterone II Gen

Source: https://www.globalkeysolutions.net/records/china_product_recall/diasorin-inc/bc80d686-4191-4306-8386-d70b25b63853/
Source feed: China

> China NMPA product recall for Progesterone Assay Kit (Chemiluminescent Immunoassay) LIAISON® Progesterone II Gen by DiaSorin Inc. published January 13, 2023. Recall level: Level 3 Recall. DiaSorin Inc. (USA) has initiated a voluntary Class III recall of its LIAISON® Progesterone II Gen P

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: DiaSorin Inc. (USA) is voluntarily recalling its LIAISON® Progesterone II Gen progesterone assay kit (chemiluminescent immunoassay).
- Company Name: DiaSorin Inc.
- Publication Date: 2023-01-13
- Product Name: Progesterone Assay Kit (Chemiluminescent Immunoassay) LIAISON® Progesterone II Gen
- 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. (USA) has initiated a voluntary Class III recall of its LIAISON® Progesterone II Gen Progesterone Assay Kit (Chemiluminescent Immunoassay). This action was publicly announced on January 13, 2023, by the National Medical Products Administration (NMPA) of China. The recall stems from a reported issue where magnetic particles within certain product models and batches may not mix properly. This manufacturing discrepancy could potentially impact the accuracy and reliability of the assay kit, which is registered under certificate number 20182402424. The recall is being managed by DiaSorin Diagnostics Medical Devices (Shanghai) Co., Ltd., on behalf of the manufacturer. While the document does not specify inspection dates, it highlights the manufacturer's proactive measure to address the product quality concern. Detailed information about the affected product models and batches is available in the associated "Medical Device Recall Event Report Form" attachment. This voluntary recall demonstrates the company's commitment to product safety and compliance with regulatory expectations under the NMPA framework, aiming to mitigate any potential risks to users and ensure the reliability of diagnostic tools.

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