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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於其熱門FreeStyle Libre 3葡萄糖監測系統的傳感器
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.

$雅培 (ABT.US)$ 據稱,發現部分FreeStyle Libre 3傳感器可能提供不正確的高血糖讀數後,雅培表示正在召回部分FreeStyle Libre 3傳感器。

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.

使用受影響的產品可能導致嚴重的不良健康後果,包括嚴重的低血糖(低血糖),可能引起中樞神經系統問題、意識喪失、抽搐、昏迷、永久性腦損傷和死亡。

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

已經報告了兩起受傷事件。沒有死亡報告。

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.

此次召回涉及將特定設備從使用或銷售的地方移除,不適用於FreeStyle Libre 3讀卡器或應用程序。

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連續葡萄糖監測系統旨在持續監測葡萄糖水平。它通過檢測葡萄糖水平的趨勢和跟蹤模式,幫助人們管理糖尿病,以便根據需要調整治療。它適用於單個病人使用,需要處方。

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,雅培向所有受影響的客戶發送了緊急醫療器械召回通知,建議停止使用、銷燬任何受影響的傳感器,並請求更換。

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

與此同時,雅培宣佈公司首款連續葡萄糖監測系統Lingo在美國可用,無需處方。

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

Lingo系統包括生物傳感器和移動應用程序,專爲希望改善整體健康和健康的消費者設計。

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

Lingo基於雅培的FreeStyle Libre持續葡萄糖監測技術。

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.

雅培的消費者生物可穿戴產品Lingo適用於18歲及以上、未使用胰島素的消費者。Lingo實時跟蹤葡萄糖水平,並提供個性化見解和指導,幫助人們養成健康習慣,重新塑造新陳代謝,改善整體健康。

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