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

Ausendo Medical Devices Trading (China) Co., Ltd., the responsible unit for manufacturer Ortho-Clinical Diagnostics, Inc., initiated a voluntary Class III recall for its Urine Protein Assay Dry Strips (Colorimetric Method). The recall was formally reported to the National Medical Products Administration (NMPA) on January 4, 2017, with public notification on March 1, 2017. The core issue prompting this action was the discovery of a potential for biased or inaccurate measurement results when the products were used to determine urine protein levels. This directly impacts the reliability of diagnostic testing. The recall, detailed in the NMPA's Medical Device Recall Event Report Form, affected 4320 boxes globally, with 3109 boxes distributed in China. As required actions, all affected customers were to be notified immediately about the potential for erroneous results. Customers were also instructed to carefully monitor the performance of any currently held urine protein assay dry strips. Furthermore, Ortho-Clinical Diagnostics, Inc. committed to promptly replacing the identified defective product batches with new, compliant units to ensure patient safety and product efficacy.