China NMPA Product Recall - Immunoglobulin G Detection Kit

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall for its Immunoglobulin G Detection Kits. This recall, reported on May 8, 2017, and overseen by the National Medical Products Administration (NMPA), addresses a critical issue identified in products from batch number M610132A. The company discovered a significant discrepancy where the parameter card barcode within the affected kits lacked the necessary suffix "A". This specific mismatch between the parameter card barcode and the kit itself resulted in an operational error, triggering a "Parameter Not Found" alarm. To ensure patient safety and product reliability, Beckman Coulter Trading (China) Co., Ltd. has taken proactive measures to recall the relevant products. Further detailed information regarding the models, specifications, and specific batches of the affected medical devices is available in the associated "Medical Device Recall Event Report Form".