China NMPA Product Recall - Fully Automatic Nucleic Acid Extraction and Purification System

Qiagen Germany has initiated a voluntary Level II recall of its Fully Automatic Sampal Preparation System, a measure reported by Qiagen Enterprise Management (Shanghai) Co., Ltd. to the National Medical Products Administration (NMPA) on November 25, 2021. The recall stems from a critical issue concerning sample identification within the device. Specifically, the system demonstrated a problem with sample ID allocation when utilizing the 2D barcode integration function, particularly during continuous sample loading operations. This defect could lead to potential misidentification of samples, thereby posing risks to the accuracy of diagnostic results and patient safety. The affected product, registered under certificate code "国械备20160121", is designed for automated sample preparation. Under the NMPA

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