Abbott initiated a voluntary medical device correction in February for certain Readers in the FreeStyle Libre family of products including FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Readers.

The FreeStyle Libre family of readers use lithium-ion batteries, like the kinds used in mobile phones and many other handheld electronic devices, which have the potential for battery swelling, leakage or extreme overheating.

We have received a limited number of reports worldwide from users over several years that their Reader’s lithium-ion battery swelled, infrequently overheated or, in very rare cases, sparked or caught fire. Our investigation has determined that using a charging cable or power adapter that was not included with your Reader may increase the risk of a fire hazard. The Abbott-provided USB cable and power adapter limit the current to safely charge the battery, whereas third-party components may allow much higher power, increasing the risk of fire if liquid or other contaminants get into the USB port.

This notice is being communicated as a voluntary medical device correction to provide information about risks associated with the lithium-ion batteries contained only in the FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Readers. No Readers are being physically recalled and customers can continue to use their Readers with the Abbott provided USB cable and power adapter. This does not affect any of the FreeStyle Libre family of sensors.

Risk to Health

It is important that you take the actions listed below to ensure your Reader is functioning properly and to reduce the risk of minor burns or fire.

Action to be Taken by Customer

To determine if your Reader needs to be replaced, click the Reader Replacement Check button below and answer the short survey.

In order to ensure that you continue to receive important information regarding your system, please visit www.LibreView.com to create an account and connect your Reader.

Action to be Taken by Company

Abbott is updating the FreeStyle Libre 14 day and FreeStyle Libre 2 Reader User’s Manuals to include the instructions below. The revised user guide and labeling are available at www.freestyle.abbott/us-en/support.

Storing the Reader, Yellow USB Cable, and Power Adapter

• DO NOT expose the Reader, power adapter or yellow USB cable to water or other liquids.
• Store the Reader between -4 °F and 140 °F.
• DO NOT place the Reader in water or other liquids. Avoid getting dust, dirt, blood, control solution, water, bleach, or any other substance in the test strip or USB port.

Charging the Reader

• Check the Reader's USB port and make sure it is dry and free of debris.
• Check the Abbott provided power adapter and yellow USB cable to make sure they are not damaged
• Use ONLY the Abbott provided power adapter and yellow USB cable that came with your Reader.
• Choose a location for charging where you can easily access the power adapter and quickly disconnect it to prevent the potential risk of electrical shock.
• Take care when plugging and unplugging your yellow USB cable. Do not force or bend the end of the yellow USB cable into the Reader’s USB port.

Using the Reader

• If the Reader becomes too hot to hold, immediately STOP USE and contact Customer Service about replacing your Reader, yellow USB cable, and power adapter.
• Do NOT use the Reader if you notice any signs of deterioration of the Reader (such as clouding or crazing on the display of the Reader, corroding, eroding or swelling of the plastic housing, or cracking of the plastic housing or display) or if the Reader does not turn on.
• If the Reader does not turn on after being charged or you notice a significant deterioration in battery life, contact Customer Service about replacing your Reader, yellow USB cable, and power adapter.
• If the Reader is dropped or subjected to impact and you are concerned it may be damaged, perform a Reader Test to confirm it is still working properly. See Perform a Reader Test section of the Reader User Manual for instructions.

The Abbott provided yellow USB cable and power adapter, that are included in your Reader Kit, are shown here.

Contact Customer Service if you need to request a replacement power adapter or yellow USB cable.

If you have any further questions or would like to report a device fault, please visit our Frequently Asked Questions (FAQs) or call Abbott Customer Service at 1-855-632-8658, available 7 days a week from 8AM to 8PM Eastern Time excluding major holidays.

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