# China NMPA Product Recall - MAS urine quality control level 2

Source: https://www.globalkeysolutions.net/records/china_product_recall/thermo-fisher-scientific-china-co-ltd/0441efaf-d3e9-4622-a593-351c39d132fa/
Source feed: China

> China NMPA product recall for MAS urine quality control level 2 by Thermo Fisher Scientific (China) Co., Ltd. published August 12, 2019. Recall level: Level 3 Recall. On August 12, 2019, Thermo Fisher Scientific (China) Co., Ltd. initiated a voluntary Level III recal

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Thermo Fisher Scientific (China) Co., Ltd. voluntarily recalls urine quality control products.
- Company Name: Thermo Fisher Scientific (China) Co., Ltd.
- Publication Date: 2019-08-12
- Product Name: MAS urine quality control level 2
- Recall Level: Level 3 Recall
- Recall Reason: Microgenics Corporation confirmed through internal investigation that it is almost impossible to detect the number of red and white blood cells under a microscope, but other analytical items of the quality control sample are not affected.
- Discovering Company: Thermo Fisher Scientific (China) Co., Ltd.
- Manufacturing Company: Thermo Fisher Scientific (China) Co., Ltd.
- Summary: On August 12, 2019, Thermo Fisher Scientific (China) Co., Ltd. initiated a voluntary Level III recall of its MAS urine quality control product, specifically Level 2, model UAB-215-Z, batch number UB1520082Z. An internal investigation by Microgenics Corporation confirmed a critical quality issue: red blood cells and white blood cells in the affected batch were almost undetectable under microscopic examination. This significantly compromised the product's reliability as a quality control standard for urine analysis, though other analytical items were not impacted. Operating under the regulatory framework of the National Medical Products Administration (NMPA) of China, as indicated by NMPA Index No. JGXX-2019-10519 and product registration certificate 国械注进20162403081, the company took required action to recall the product. Detailed information on affected models and specifications is provided in the Medical Device Recall Event Report Form, ensuring product integrity and upholding diagnostic testing standards.

Company: https://www.globalkeysolutions.net/companies/thermo-fisher-scientific-china-co-ltd/580e6795-f6cb-4d91-afd1-d1d8602f0dca/