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

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/e49c9854-2f37-4984-ba3b-74b52f2c1eed/
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. The National Medical Products Administration (NMPA) published a notice on October 11, 2017, concerni

---

## 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: The National Medical Products Administration (NMPA) published a notice on October 11, 2017, concerning a voluntary product recall initiated by BioMérieux Diagnostics (Shanghai) Co., Ltd. The recall pertains to specific batches of their Testosterone Monitoring Kit (Enzyme-Linked Fluorescence Assay), registered under No.: 20162401716. BioMérieux Diagnostics (Shanghai) Co., Ltd. reported that certain batches of this diagnostic product yielded test results that did not meet the acceptable performance range. This significant quality issue led the company to voluntarily recall the affected kits. The recall is classified as Level II, indicating a situation where the use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. This action falls under the regulatory framework of the NMPA, which oversees medical devices in China. The company is required to provide detailed information on the specific models, specifications, and batch numbers of the recalled products in a "Medical Device Recall Event Report Form." This recall highlights the critical importance of product quality and patient safety within the medical diagnostic industry, ensuring that diagnostic tools deliver accurate and reliable results.

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