China NMPA Product Recall - AQT90 FLEX Analyzer Fully Automated Fluorescence Immunoassay Analyzer

Redormet Medical Equipment (Shanghai) Co., Ltd. has initiated a voluntary Class III recall of its AQT90 FLEX Analyzer (Automated Fluorescence Immunoassay Analyzer), as announced by the National Medical Products Administration (NMPA) on May 7, 2020. This action addresses a critical safety concern: the device's potential to misread patient identification barcodes. Specifically, when users employ self-printed barcodes that are unclear and lack check digits, there is a risk of inaccurate identification. This flaw could lead to patient confusion or significant delays in medical treatment, posing a direct threat to patient care and safety.

While no specific inspection dates are detailed, this proactive recall by Redormet Medical Equipment (Shanghai) Co., Ltd. demonstrates a commitment to product quality and patient safety under the NMPA's regulatory framework. The required action involves the recall of all affected fully automated fluorescence immunoassay analyzers. Comprehensive details regarding the specific models, specifications, and batch numbers impacted by this recall are provided in the accompanying "Medical Device Recall Event Report Form." This incident underscores the paramount importance of robust barcode integrity in medical diagnostic equipment to prevent adverse patient outcomes.