China NMPA Product Recall - CytoLyt Solution (Cell Washing Solution)

Hologic, Inc., through its subsidiary Hologic Medical Technology (Beijing) Co., Ltd., has initiated a voluntary recall of its CytoLyt Solution. This action, published on December 1, 2025, follows reports from US customers concerning suspected fungal contamination identified in specific product batches. An internal assessment revealed that this contamination presents a moderate health risk to patients. The primary concern is the potential for misinterpretation of laboratory results, which could lead to inappropriate clinical interventions. Specifically, there is a risk that healthcare providers might initiate unnecessary or incorrect antifungal therapies based on compromised test outcomes. This recall is managed under the oversight of the National Medical Products Administration (NMPA) of China, referencing the product's National Medical Device Registration Certificate (20140214). The company has provided detailed information regarding the affected product models, specifications, and batch numbers in an accompanying Medical Device Recall Event Report Form. Hologic is proactively withdrawing the impacted CytoLyt Solution from the market to mitigate potential patient risks and ensure product safety and reliability.