China NMPA Product Recall - MAS urine quality control level 2

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.