China NMPA Product Recall - Microalbumin assay kit (turbidimetric assay), Alpha-1-Microglobulin assay kit (turbidimetric assay), Urine Transferrin (turbidimetric assay)

On December 6, 2024, Beckman Coulter, Inc., through its subsidiary Beckman Coulter Trading (China) Co., Ltd., initiated a voluntary Class III recall of several medical device products under the oversight of the National Medical Products Administration (NMPA) in China. The affected products include the Microalbumin (turbidimetric assay) kit, Alpha-1-Microglobulin assay kit (turbidimetric assay), and Urine Transferrin (turbidimetric assay) kit. The primary reason for this recall is identified as an error in the instruction manuals accompanying these assay kits. This action is a proactive measure by Beckman Coulter to address the identified discrepancy. As part of the regulatory framework, this is categorized as a Class III recall, indicating a situation where use of or exposure to a recalled product is not likely to cause adverse health consequences. Affected parties are directed to refer to the 'Medical Device Recall Event Report Form' for comprehensive details regarding specific product models, specifications, and batch numbers involved in this recall.