China NMPA Product Recall - Automated Digital Cell Morphology Analyzer

CellaVision AB, in collaboration with Sysmex Medical Electronics (Shanghai) Co., Ltd., has initiated a voluntary Class II recall for its Automated Digital Cell Morphology Analyzer (National Medical Device Registration Certificate No. 20192221). This action, announced by the National Medical Products Administration (NMPA) on November 7, 2025, addresses a critical product issue. The primary concern involves the risk of barcode reading errors and detection inaccuracies when a specific barcode reader is utilized with slides containing unreadable barcodes in the DI-60 device. This defect could potentially compromise the accuracy and reliability of diagnostic data generated by the analyzer.

Operating under the NMPA's regulatory framework, CellaVision AB's proactive recall aims to mitigate potential patient safety risks and ensure the device adheres to performance standards. It is important to note that the specific product batches subject to this recall were not imported into the Chinese market, thereby localizing the immediate impact of the recall. Sysmex Medical Electronics (Shanghai) Co., Ltd. was responsible for reporting this event. This voluntary recall exemplifies a commitment to upholding medical device quality and compliance with established regulatory protocols, even in instances where affected products are not locally distributed.