China NMPA Product Recall - Interleukin-6 calibrator

This document, published by the National Medical Products Administration (NMPA) on December 5, 2018, details a voluntary Level III recall initiated by Beckman Coulter Trading (China) Co., Ltd. The recall pertains to their Interleukin-6 Calibrators, specifically batch number 724582 (Registration Certificate No.: 20152403254). The core issue identified was that the affected batch failed to meet its stated stability requirements when stored unopened at 2-10℃. This stability deviation poses a significant risk to quality control procedures and could potentially compromise patient diagnoses by leading to inaccurate test results. The company undertook this recall voluntarily, operating under the regulatory framework of the NMPA, specifically referenced as "Shanghai Food and Drug Administration Medical Device Recall 2018-272." As a required action, Beckman Coulter Trading (China) Co., Ltd. has commenced a Level III recall to remove the non-conforming Interleukin-6 Calibrators from circulation. Comprehensive details, including specific product models, specifications, and additional batch information, are provided in an accompanying "Medical Device Recall Event Report Form." This proactive measure is critical for safeguarding public health and maintaining the integrity of medical device quality standards.