China NMPA Product Recall - ACCELERATOR a3600 Sample Processing System

The National Medical Products Administration (NMPA) announced on November 8, 2021, a voluntary Class II recall initiated by Abbott Group Switzerland, with Abbott Trading (Shanghai) Co., Ltd. reporting the issue. This recall concerns the ACCELERATOR a3600 sample processing system (Registration No.: 20161009). The core problem identified is a critical malfunction within an interface module that may incorrectly link sample results with erroneous sample IDs, potentially leading to significant inaccuracies in patient data or diagnostic outcomes. Operating under the NMPA's regulatory framework for medical devices, the manufacturer is proactively addressing this deficiency to ensure patient safety and data integrity. Detailed information regarding the specific affected product models, specifications, and batches is available in the provided "Medical Device Recall List" and the "Medical Device Recall Event Report Form." Organizations and users utilizing the ACCELERATOR a3600 system are required to consult these detailed documents for precise instructions on managing and returning the affected products.