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

The National Medical Products Administration (NMPA) has documented a voluntary Class III recall initiated by Ortho-Clinical Diagnostics, Inc. (USA), in collaboration with its subsidiary, Ortho-Clinical Diagnostics Medical Devices Trading (China) Co., Ltd. This recall pertains to the Urine Protein Assay Dry Strips (Colorimetric Method), identified by Registration Certificate No. 20152402859. The primary reason for this action is an identified error in the translation of the product's Italian instructions for use. The NMPA announcement details this recall event, emphasizing the company's proactive measure rather than an inspection finding on specific dates. Operating under the regulatory framework of the NMPA, which oversees medical devices in China, the company is undertaking this voluntary recall to address potential user comprehension issues stemming from the inaccurate translation. Specific details regarding the affected product models, specifications, and batch numbers are provided in an attached "Medical Device Recall Event Report Form" referenced within the NMPA's public notice. This action highlights the critical importance of precise product documentation and clear instructions for medical device safety and proper usage in global markets.