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

Source: https://www.globalkeysolutions.net/records/china_product_recall/hologic-inc/a7d15b14-fe92-45dd-a2c9-853f6f83b0fb/
Source feed: China

> China NMPA product recall for CytoLyt Solution (Cell Washing Solution) by Hologic, Inc. published December 01, 2025. Recall level: . Hologic, Inc., through its subsidiary Hologic Medical Technology (Beijing) Co., Ltd., has initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Hologic, Inc. is voluntarily recalling its CytoLyt Solution, a cell washing solution.
- Company Name: Hologic, Inc.
- Publication Date: 2025-12-01
- Product Name: CytoLyt Solution (Cell Washing Solution)
- Recall Reason: We received a complaint from a US customer regarding suspected fungal contamination in a specific batch of products. An assessment indicates a moderate health risk that could lead to misinterpretation of laboratory results, potentially resulting in bedside interventions (such as antifungal treatment).
- Discovering Company: Hologic Technologies (Beijing) Co., Ltd.
- Manufacturing Company: Hologic, Inc.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/hologic-inc/bf654f75-4802-4fb4-9387-5706aec9ac0d/