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

Abbott (Shanghai) Diagnostics Sales Co., Ltd. initiated a voluntary Class III recall of its Alere Afinion AS100 Analyzer (Registration Certificate No.: 20192222131). This recall, announced on July 15, 2021, by the Shanghai Municipal Drug Administration under notice No. 2021-140, addresses a critical issue with the device's electronic motherboard. The core problem identified is that if the Afinion™ Analyzer is stored without power for an extended period, specifically 1.5 to 2 years, its internal clock battery may deplete prematurely, failing before the analyzer's anticipated lifespan. This premature battery depletion leads to the analyzer failing its internal self-test and subsequently malfunctioning, compromising its intended diagnostic capabilities. The regulatory oversight for this action falls under the National Medical Products Administration (NMPA) and its provincial arm, the Shanghai Municipal Drug Administration, which formally issued the recall notice. Abbott (Shanghai) Diagnostics Sales Co., Ltd. is taking the required action of a voluntary recall to mitigate potential risks associated with the malfunctioning analyzers. Detailed information regarding the specific affected product models, specifications, and batch numbers is provided in an accompanying Medical Device Recall Event Report Form, ensuring full transparency and facilitating the recall process for distributors and users. This proactive measure aims to maintain product quality and patient safety standards within the medical device industry.