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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.

爱伯特公司在美国就部分FreeStyle Libre 3传感器发出自愿性的器械更正通知。
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
  • 这种自愿的医疗器械校正仅影响美国三个批次中的一小部分 FreeStyle Libre 3 传感器
  • 消费者可以到访,看看他们的传感器是否受到影响,并免费换货
  • 没有其他 FreeStyle Libre 系列产品或国家受到影响

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.

伊利诺伊州雅培公园,2024年7月24日——雅培已开始对2024年5月上半月在美国分发的少量FreeStyle Libre 3传感器进行自愿医疗器械更正。

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 系统包括传感器、阅读器和应用程序。这种医疗设备校正仅影响传感器。FreeStyle Libre 3 阅读器和应用程序不受影响。

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.

内部测试确定,三个批次中的一些传感器可能提供不正确的高血糖读数,如果不被发现,可能会对糖尿病患者构成潜在的健康风险,并可能导致错误的治疗决定,例如在不需要时服用胰岛素。

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

此问题仅影响以下三个批号内的 FreeStyle Libre 3 传感器的一小部分:

  • 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).

如果消费者拥有其他批次的FreeStyle Libre 3传感器,则无需采取行动,他们可以继续使用传感器。对居住在美国境外或使用其他 FreeStyle Libre 产品(FreeStyle Libre 14 天、FreeStyle Libre 2 或 FreeStyle Libre 2 Plus)的用户没有影响。

How to Identify Lot or Serial Number

如何识别批号或序列号

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.

如果传感器仍在包装中,则可以在纸箱包装底部找到批次和序列号(标识为 “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 .

如果传感器当前正在使用或可能已经被使用,则序列号可以显示在 FreeStyle Libre 3 应用程序或阅读器中。有关查找序列号的更多详细说明,请访问。

Checking if the Sensor is Affected

检查传感器是否受到影响

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.

如果上面列出了消费者的产品批号,他们需要访问,选择 “确认传感器序列号”,然后输入序列号,以确认他们的传感器是否受到这种自愿医疗器械更正的影响。佩戴受影响的 FreeStyle Libre 3 传感器的消费者应立即停止使用并处置他们拥有的任何受影响的传感器。如果消费者的传感器受到影响,他们将需要输入联系信息,这样 Abbott 才能免费向他们发送替换传感器。

"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."

雅培糖尿病护理业务执行副总裁贾里德·沃特金说:“我们对这可能给我们的客户带来的干扰深表歉意。”“我们正在积极与美国食品药品监督管理局和分销商合作,并向受影响的客户提供信息,他们将尽快免费获得替代品。”

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.

如果消费者出现与传感器血糖读数不符的症状或怀疑读数可能不准确,他们将被要求使用任何血糖仪进行指尖测试。FreeStyle Libre 3 阅读器中的内置血糖计可用于随时检查血糖。

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.

消费者可以访问以了解更多信息或拨打客户服务热线1-833-815-4273,每周七天提供服务,美国东部时间上午8点至晚上8点,节假日除外。

About Abbott:

关于雅培:

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 是全球医疗保健领导者,致力于帮助人们在生命的各个阶段过上更充实的生活。我们的改变生活的技术组合涵盖医疗保健领域,在诊断、医疗器械、营养品和品牌仿制药方面拥有领先的业务和产品。我们的 114,000 名同事为 160 多个国家的人们提供服务。通过领英、脸书、Instagram、X 和 YouTube 联系我们。

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

重要安全信息:
产品仅供处方使用,有关重要安全信息,请访问。

声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
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