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Abbott Laboratories Recalls Some Sensors For Its Popular FreeStyle Libre 3 Glucose Monitoring System

Abbott Laboratories Recalls Some Sensors For Its Popular FreeStyle Libre 3 Glucose Monitoring System

雅培公司召回了一些用于其热门FreeStyle Libre 3葡萄糖监测系统的传感器
Benzinga ·  09/05 14:54

$Abbott Laboratories (ABT.US)$ said it is recalling some FreeStyle Libre 3 sensors after finding that a small number of FreeStyle Libre 3 sensors may provide incorrect high glucose readings.

$雅培 (ABT.US)$ 据称,发现部分FreeStyle Libre 3传感器可能提供不正确的高血糖读数后,雅培表示正在召回部分FreeStyle Libre 3传感器。

The use of the affected product may cause serious adverse health consequences, including severe low blood sugar (hypoglycemia), which can cause central nervous system problems, loss of consciousness, seizures, coma, permanent brain damage, and death.

使用受影响的产品可能导致严重的不良健康后果,包括严重的低血糖(低血糖),可能引起中枢神经系统问题、意识丧失、抽搐、昏迷、永久性脑损伤和死亡。

There have been two reported injuries. There have been no reports of death.

已经报告了两起受伤事件。没有死亡报告。

This recall involves removing certain devices from where they are used or sold and does not apply to the FreeStyle Libre 3 reader or app.

此次召回涉及将特定设备从使用或销售的地方移除,不适用于FreeStyle Libre 3读卡器或应用程序。

The FreeStyle Libre 3 Continuous Glucose Monitoring System is intended to monitor glucose levels continuously. It helps people manage diabetes by detecting trends and tracking patterns in glucose levels so treatment can be adjusted as needed. It is indicated for single-patient use and requires a prescription.

FreeStyle Libre 3连续葡萄糖监测系统旨在持续监测葡萄糖水平。它通过检测葡萄糖水平的趋势和跟踪模式,帮助人们管理糖尿病,以便根据需要调整治疗。它适用于单个病人使用,需要处方。

In July, Abbott sent all affected customers an Urgent Medical Device Recall recommending discontinuing the use, disposing of any affected sensors, and requesting a replacement.

7月,雅培向所有受影响的客户发送了紧急医疗器械召回通知,建议停止使用、销毁任何受影响的传感器,并请求更换。

Concurrently, on Thursday, Abbott announced the U.S. availability of Lingo, the company's first continuous glucose monitoring system, without a prescription.

与此同时,雅培宣布公司首款连续葡萄糖监测系统Lingo在美国可用,无需处方。

The Lingo system includes a biosensor and a mobile app designed for consumers who want to improve their overall health and wellness.

Lingo系统包括生物传感器和移动应用程序,专为希望改善整体健康和健康的消费者设计。

Lingo is based on Abbott's FreeStyle Libre continuous glucose monitoring technology.

Lingo基于雅培的FreeStyle Libre持续葡萄糖监测技术。

Abbott's consumer biowearable, Lingo, is available for consumers 18 years and older not on insulin. Lingo tracks glucose in real-time and provides personal insights and coaching to help people build healthy habits, retrain their metabolism, and improve their overall well-being.

雅培的消费者生物可穿戴产品Lingo适用于18岁及以上、未使用胰岛素的消费者。Lingo实时跟踪葡萄糖水平,并提供个性化见解和指导,帮助人们养成健康习惯,重新塑造新陈代谢,改善整体健康。

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