China NMPA Product Recall - AQT90 FLEX Analyzer, a fully automated fluorescence immunoassay analyzer

Radomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its AQT90 FLEX Automated Fluorescence Immunoassay Analyzer. This action, reported on December 11, 2020, was publicly announced through the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The company became aware that the analyzer may experience a "time reset error" if an incorrect power-off sequence is executed. This specific operational malfunction prompted the company to proactively recall affected devices to address the issue and maintain product integrity. The recall is detailed in NMPA Index No. JGXX-2020-10691 and Shanghai Drug Administration Recall No. 2020-244, with further specifics on product models, specifications, and batches available in the