China NMPA Product Recall - 17α-Hydroxyprogesterone Assay Kit (Time-Resolved Fluorescence Assay)

Platinum Elmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its 17α-Hydroxyprogesterone Assay Kit (Time-Resolved Fluorescence Assay) (Registration No.: 20153402061). This recall, reported by the company, addresses a critical error found in the labeling of product components. The National Medical Products Administration (NMPA) published this information on July 14, 2017, referencing index number JGXX-2017-10586. The company's proactive measure ensures compliance with regulatory standards by addressing the identified labeling discrepancy. Detailed information regarding affected models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form." This action underscores the company's commitment to product safety and regulatory adherence under the NMPA framework, requiring the immediate withdrawal of the affected kits from the market to mitigate any potential risks associated with mislabeled components.