China NMPA Product Recall - Fully Automated Nucleic Acid Extraction, Purification, and Medical PCR Analysis System

On July 19, 2019, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its fully automated nucleic acid extraction, purification, and medical PCR analysis system, specifically the cobas 6800/8800 models. This action was prompted by complaints received by Roche Diagnostics headquarters regarding the failure of the processing transport head to pass the airtightness check within the system's separation and purification module. Investigations revealed droplet traces on critical internal components, indicating a leakage issue with the processing transport head. This malfunction carries a significant risk of producing invalid or false positive test results, which could adversely impact diagnostic accuracy. The recall is being managed under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, as evidenced by NMPA Index No. JGXX-2019-10452. The company is undertaking this recall to address the identified product malfunction, safeguard patient outcomes, and ensure the integrity of diagnostic data. Further details regarding affected product models, specifications, and batches are provided in the accompanying Medical Device Recall Event Report Form.