# China NMPA Product Recall - Activated Coagulation Time Assay Kit (Coagulation Method) HR-ACT Cartridge

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/b0952024-a777-4fdf-99fa-8a7484d521ce
Source feed: China

> China NMPA product recall for Activated Coagulation Time Assay Kit (Coagulation Method) HR-ACT Cartridge by Medtronic Inc. published December 02, 2025. Recall level: Level 2 Recall. Medtronic Inc., through its subsidiary Medtronic (Shanghai) Management Co., Ltd., has initiated a vo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is voluntarily recalling its Activated Coagulation Time Assay Kit (Clotting Method) HR-ACT Cartridge.
- Company Name: Medtronic Inc.
- Publication Date: 2025-12-02
- Product Name: Activated Coagulation Time Assay Kit (Coagulation Method) HR-ACT Cartridge
- Recall Level: Level 2 Recall
- Recall Reason: Blood loss marks on the outer carton label and instruction manual (IFU) of 5 boxes of a specific model and batch of activated clotting time assay kit (coagulation method).
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc., through its subsidiary Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Level II recall for its Activated Coagulation Time Assay Kit (Clotting Method) HR-ACT Cartridge. The recall was prompted by the discovery of bloodstains on the outer carton label and instruction manual of five boxes from a specific batch of the product at Medtronic Global. This issue was identified internally by Medtronic (Shanghai) Management Co., Ltd. and subsequently reported to the National Medical Products Administration (NMPA).

While no complaints or adverse events related to these specific contaminated products have been reported to date, the company is proactively recalling the affected kits to uphold product integrity and ensure patient safety. This action aligns with the regulatory framework set by the NMPA, with the affected product holding Medical Device Registration Certificate No. 20172401652. The required action involves the voluntary removal of the impacted products from the market. Further specific details regarding models, specifications, and batch numbers are provided in the comprehensive "Medical Device Recall Event Report Form" attached to the public notice. This recall highlights Medtronic's commitment to quality control and compliance under regulatory oversight.

Company: https://www.globalkeysolutions.net/companies/medtronic-inc/398d5f72-c7d2-4c97-94fc-fbef4cf2336d