China NMPA Product Recall - Urine protein assay dry slide (colorimetric method)

Ausendo Medical Devices Trading (China) Co., Ltd. has initiated a voluntary Class III recall of its Urine Protein Assay Dry Strips (Colorimetric Method). The company identified that these medical devices produced biased measurement results when used to detect urine protein, prompting the recall to ensure product reliability and patient safety. This action, reported on February 21, 2017, falls under the regulatory oversight of the National Medical Products Administration (NMPA). While not a result of an NMPA inspection, Ausendo proactively reported the issue and commenced the recall process as per regulatory expectations for addressing product deficiencies. The company's required action involves retrieving the affected products from the market. Specific details regarding the recalled products, including product numbers, specifications, and batch numbers, are documented in a comprehensive 'Medical Device Recall Event Report Form' provided by Ausendo. This voluntary recall underscores the company's commitment to product quality and compliance with medical device regulations in China.