# China NMPA Product Recall - Testosterone monitoring kit (ELISA)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/60bf9797-e62d-44cb-8bbe-afa35f21ad9d/
Source feed: China

> China NMPA product recall for Testosterone monitoring kit (ELISA) by Roche Diagnostics Products (Shanghai) Co., Ltd. published October 11, 2017. Recall level: Level 2 Recall. BioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Level II recall for specific batch

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its testosterone monitoring kits (ELISA).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2017-10-11
- Product Name: Testosterone monitoring kit (ELISA)
- Recall Level: Level 2 Recall
- Recall Reason: The issue involves specific batches of products having test results that are outside the acceptable range.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: BioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Level II recall for specific batches of its Testosterone Monitoring Kit (Enzyme-Linked Fluorescence Assay), registered under No. 20162401716. The recall, publicly announced by the National Medical Products Administration (NMPA) on October 11, 2017, was prompted by the company's internal finding that certain product batches yielded test results outside their acceptable performance range. This deviation indicates a potential impact on the accuracy and reliability of diagnostic testing performed with these kits, posing a risk to patient care and clinical decision-making. Under the oversight of the NMPA, BioMérieux Diagnostics (Shanghai) Co., Ltd. is responsible for identifying and retrieving all affected products from distribution channels and end-users. The Level II classification signifies that the use of these defective products could cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The company is required to provide detailed information regarding the specific models, specifications, and batch numbers of the affected kits in a "Medical Device Recall Event Report Form" to facilitate the recall process and ensure all stakeholders are informed. This proactive measure aims to mitigate potential risks associated with inaccurate diagnostic results and uphold product safety standards.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9/