China NMPA Product Recall - Specialty Protein Dry Immunophenochromatography Analyzer Alere Afinion AS100 Analyzer

On January 27, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Abbott (Shanghai) Diagnostic Products Sales Co., Ltd. This action concerns the Alere Afinion AS100 Analyzer for Special Protein Dry Immunochromatography. The manufacturer, Abbott Diagnostics Technologies AS, decided to proceed with the recall following numerous customer complaints. These complaints specifically detailed incidents of electrostatic discharge and sparks originating from the power cord and power adapter supplied with the analyzer. Such occurrences led to reported damage to these essential components, subsequently causing the device to malfunction. Under the oversight of the NMPA, Abbott Diagnostics Technologies AS has proactively undertaken a voluntary recall of the affected "Special Protein Dry Immunochromatographic Analyzer." This measure directly addresses the product quality and safety concerns raised by these reported defects, ensuring device reliability and patient safety. Further details, including specific product models and batch numbers, are available in the comprehensive Medical Device Recall Event Report Form, which was issued alongside the official announcement.