China NMPA Product Recall - Genetic Analyzer

InfoJet (Shanghai) Trading Co., Ltd., in collaboration with manufacturer Life Technologies Holdings Pte Ltd, initiated a voluntary Class III recall of its 3500 Dx Genetic Analyzers in China. This action, reported on August 3, 2021, by the National Medical Products Administration (NMPA), stemmed from customer complaints and an subsequent internal investigation. The primary issue identified was an error on the Chinese labels of a small number of these analyzers. The labels incorrectly displayed an expired medical device registration certificate number (20162400211) instead of the valid and current one (20162220211). While this labeling discrepancy does not impact the product's functionality or safety, it constitutes a non-compliance with regulatory labeling requirements under the NMPA framework. As a required action, InfoJet (Shanghai) Trading Co., Ltd. committed to configuring new Chinese labels with the correct medical device registration number for all affected 3500 Dx Genetic Analyzers. The recall aims to rectify the labeling inaccuracy to ensure full regulatory compliance, although the product remains safe and fit for its intended use. Detailed information on specific models, specifications, and batches is provided in the associated "Medical Device Recall Event Report Form."