# China NMPA Product Recall - Continuous Glucose Monitoring Recorder Set; Continuous glucose monitoring system

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-shanghai-management-co-ltd/f14676c2-de45-44bf-a88e-eb120441787d/
Source feed: China

> China NMPA product recall for Continuous Glucose Monitoring Recorder Set; Continuous glucose monitoring system by Medtronic (Shanghai) Management Co., Ltd. published March 15, 2021. Recall level: Level 2 Recall. On March 15, 2021, the National Medical Products Administration (NMPA) announced that Medtronic (Sha

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. is proactively recalling its Continuous Glucose Monitoring Recorder Set (a continuous glucose monitoring system).
- Company Name: Medtronic (Shanghai) Management Co., Ltd.
- Publication Date: 2021-03-15
- Product Name: Continuous Glucose Monitoring Recorder Set; Continuous glucose monitoring system
- Recall Level: Level 2 Recall
- Recall Reason: The drug hydroxyurea (HU) may interfere with the chemical reaction of the sensor probe, resulting in inaccurate (high) SG readings.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic (Shanghai) Management Co., Ltd.
- Summary: On March 15, 2021, the National Medical Products Administration (NMPA) announced that Medtronic (Shanghai) Management Co., Ltd. initiated a proactive, voluntary Class II recall for its Continuous Glucose Monitoring Recorder Set (Registration Certificate Nos.: 20153070599; 20203070391). The company identified a significant issue where the drug "hydroxyurea" (HU) could potentially interfere with the chemical reaction of the sensor probe, resulting in inaccurate, specifically high, sensor glucose (SG) readings. Although Medtronic reported no complaints or adverse health effects related to this issue, the decision to recall was based on a principle of patient prioritization. As part of this action, Medtronic launched a safety notification campaign to inform current users of the Continuous Glucose Monitoring System about the potential interference. The campaign advises users to implement appropriate measures if they are taking hydroxyurea, emphasizing that this specific user-facing notification does not necessitate a physical return of the affected devices. This regulatory action aims to ensure patient safety and product reliability.

Company: https://www.globalkeysolutions.net/companies/medtronic-shanghai-management-co-ltd/e5ba243d-a47a-4442-84d4-1e11f92f75e2/