China NMPA Product Recall - Apolipoprotein B Assay Kit (Immunoturbidimetric Method)

On June 29, 2019, Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Apolipoprotein B Assay Kit (Immunoturbidimetric Assay), specifically affecting batch M810066. This action was prompted by the discovery of incorrect setpoint target values for the Apolipoprotein B (APOB) calibration solution, which were detailed in the product's important information. The issue could potentially lead to inaccurate test results when using the affected kits. The recall was reported by the Shanghai Food and Drug Administration and overseen by the National Medical Products Administration (NMPA) of China, indicating adherence to national medical device safety regulations. The company voluntarily undertook this recall to address the quality deviation and ensure product reliability. While the specific detailed actions beyond the recall itself, such as product return or replacement procedures, are not outlined in this public notice, further information was made available in a Medical Device Recall Event Report Form. This recall underscores the company's responsibility in maintaining product quality and compliance with regulatory standards set by the NMPA, safeguarding patient diagnostic accuracy.