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Abbott Issues Voluntary Medical Device Correction for a Small Number of FreeStyle Libre 3 Sensors in the U.S.

Abbott Issues Voluntary Medical Device Correction for a Small Number of FreeStyle Libre 3 Sensors in the U.S.

愛伯特公司在美國就部分FreeStyle Libre 3傳感器發出自願性的器械更正通知。
Abbott ·  07/24 00:00
  • This voluntary medical device correction impacts a small subset of FreeStyle Libre 3 sensors from among those within three lots in the U.S. only
  • Consumers can visit to see if their sensors are affected and to get a replacement at no charge
  • No other FreeStyle Libre family of products or countries are impacted
  • 這種自願的醫療器械校正僅影響美國三個批次中的一小部分 FreeStyle Libre 3 傳感器
  • 消費者可以到訪,看看他們的傳感器是否受到影響,並免費換貨
  • 沒有其他 FreeStyle Libre 系列產品或國家受到影響

ABBOTT PARK, Ill., July 24, 2024 – Abbott has initiated a voluntary medical device correction for a small number of FreeStyle Libre 3 sensors distributed in the United States during the first half of May 2024.

伊利諾伊州雅培公園,2024年7月24日——雅培已開始對2024年5月上半月在美國分發的少量FreeStyle Libre 3傳感器進行自願醫療器械更正。

The FreeStyle Libre 3 system includes a sensor, reader and app. This medical device correction impacts the sensor only. The FreeStyle Libre 3 reader and app are not impacted.

FreeStyle Libre 3 系統包括傳感器、閱讀器和應用程序。這種醫療設備校正僅影響傳感器。FreeStyle Libre 3 閱讀器和應用程序不受影響。

Internal testing determined that some of the sensors from among three lots may provide incorrect high glucose readings, which if undetected may pose a potential health risk for people living with diabetes and can lead to incorrect treatment decisions, such as taking insulin when not required.

內部測試確定,三個批次中的一些傳感器可能提供不正確的高血糖讀數,如果不被發現,可能會對糖尿病患者構成潛在的健康風險,並可能導致錯誤的治療決定,例如在不需要時服用胰島素。

This issue affects only a small subset of FreeStyle Libre 3 sensors from among those within the following three lot numbers:

此問題僅影響以下三個批號內的 FreeStyle Libre 3 傳感器的一小部分:

  • T60001948
  • T60001966
  • T60001969
  • T60001948
  • T60001966
  • T60001969

If consumers have FreeStyle Libre 3 sensors from other lots, there is no need to take action and they can continue to use their sensors. There is no impact for users who live outside of the U.S. or use other FreeStyle Libre products (FreeStyle Libre 14 day, FreeStyle Libre 2, or FreeStyle Libre 2 Plus).

如果消費者擁有其他批次的FreeStyle Libre 3傳感器,則無需採取行動,他們可以繼續使用傳感器。對居住在美國境外或使用其他 FreeStyle Libre 產品(FreeStyle Libre 14 天、FreeStyle Libre 2 或 FreeStyle Libre 2 Plus)的用戶沒有影響。

How to Identify Lot or Serial Number

如何識別批號或序列號

If the sensor is still in the package, the lot and serial number (identified as "SN") can be found on the bottom of the carton's packaging.

如果傳感器仍在包裝中,則可以在紙箱包裝底部找到批次和序列號(標識爲 “SN”)。

If the sensor is currently in use or may have already been used, the serial number can be displayed within the FreeStyle Libre 3 app or reader. More detailed instructions on locating the serial number can be found by visiting .

如果傳感器當前正在使用或可能已經被使用,則序列號可以顯示在 FreeStyle Libre 3 應用程序或閱讀器中。有關查找序列號的更多詳細說明,請訪問。

Checking if the Sensor is Affected

檢查傳感器是否受到影響

If the consumer's product lot number is listed above, they need to visit , select "Confirm Sensor Serial Number," and enter their serial number to confirm whether their sensor is affected by this voluntary medical device correction. Consumers wearing an affected FreeStyle Libre 3 sensor should immediately discontinue use and dispose of any affected sensors in their possession. If the consumer's sensor is impacted they will need to enter their contact information so Abbott can send them a replacement sensor at no charge.

如果上面列出了消費者的產品批號,他們需要訪問,選擇 “確認傳感器序列號”,然後輸入序列號,以確認他們的傳感器是否受到這種自願醫療器械更正的影響。佩戴受影響的 FreeStyle Libre 3 傳感器的消費者應立即停止使用並處置他們擁有的任何受影響的傳感器。如果消費者的傳感器受到影響,他們將需要輸入聯繫信息,這樣 Abbott 才能免費向他們發送替換傳感器。

"We sincerely regret the disruption this may have on our customers," said Jared Watkin, executive vice president of Abbott's diabetes care business. "We're actively working with the U.S. Food and Drug Administration and distributors, as well as providing information to affected customers, who will receive replacements at no charge as quickly as possible."

雅培糖尿病護理業務執行副總裁賈裏德·沃特金說:“我們對這可能給我們的客戶帶來的干擾深表歉意。”“我們正在積極與美國食品藥品監督管理局和分銷商合作,並向受影響的客戶提供信息,他們將盡快免費獲得替代品。”

Consumers are instructed to conduct a fingerstick test using any blood glucose meter if they experience symptoms that do not match the sensor glucose reading or suspect the reading may be inaccurate. The built-in blood glucose meter in the FreeStyle Libre 3 reader may be used to check glucose at any time.

如果消費者出現與傳感器血糖讀數不符的症狀或懷疑讀數可能不準確,他們將被要求使用任何血糖儀進行指尖測試。FreeStyle Libre 3 閱讀器中的內置血糖計可用於隨時檢查血糖。

Consumers can visit to learn more or call customer service at 1-833-815-4273, available seven days a week from 8 a.m. to 8 p.m. Eastern Time, excluding holidays.

消費者可以訪問以了解更多信息或撥打客戶服務熱線1-833-815-4273,每週七天提供服務,美國東部時間上午8點至晚上8點,節假日除外。

About Abbott:

關於雅培:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Connect with us at and on LinkedIn, Facebook, Instagram, X and YouTube.

Abbott 是全球醫療保健領導者,致力於幫助人們在生命的各個階段過上更充實的生活。我們的改變生活的技術組合涵蓋醫療保健領域,在診斷、醫療器械、營養品和品牌仿製藥方面擁有領先的業務和產品。我們的 114,000 名同事爲 160 多個國家的人們提供服務。通過領英、臉書、Instagram、X 和 YouTube 聯繫我們。

Important Safety Information:
Product for prescription only, for Important Safety Information, please visit .

重要安全信息:
產品僅供處方使用,有關重要安全信息,請訪問。

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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