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Product Recall – Freestyle Libre 3 and Libre 3 Plus Sensors

If you recently ordered a – Freestyle Libre 3 and Libre 3 Plus Sensor from CenterWell Mail Order Pharmacy, we want to let you know that Abbott, the manufacturer of the – Freestyle Libre 3 and Libre 3 Plus Sensors, has issued a voluntary recall of certain lots of these blood sugar monitoring medical devices (www.FreeStyleCheck.com). Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after internal testing determined that some sensors may provide incorrect low glucose readings.

This issue is isolated to certain lots of the Freestyle Libre 3 and Libre 3 Plus Sensors (see product details below) and does not affect other Freestyle products or diabetic monitoring supplies you may have received from CenterWell Mail Order Pharmacy. telephone at 855-544-9419, Monday – Friday, 8 a.m. – 11 p.m. and Saturday, 8 a.m. – 6:30 p.m., Eastern time.

What to do:

Consumers should visit www.FreeStyleCheck.com to confirm whether their sensor is potentially affected by this medical device correction. Abbott will replace any potentially affected sensors at no charge. Detailed instructions on how to check sensors and request a replacement are available on www.FreeStyleCheck.com.

If consumers are currently wearing or have a sensor that has been confirmed as potentially impacted on www.FreeStyleCheck.com or by a customer service representative, they should immediately discontinue use and dispose of it.

Consumers should use a blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader to make treatment decisions when sensor readings don’t match symptoms or expectations.

To learn more or get help with questions, visit www.FreeStyleCheck.com or call Abbott’s customer service at 1-833-815-4273, available seven days a week from 8 a.m. to 8 p.m. Eastern Time. Agents are available 24/7 through live chat at https://www.freestyle.abbott/us-en/support/contact-us.html.

TRUE METRIX®, TRUE METRIX® AIR and TRUE METRIX® GO Self-Monitoring Blood Glucose Systems – E-5 Error Code Instructions

Consumer Notice

Trividia is updating the E-5 Error Code in the “Messages” section of the Owner’s Booklets/System Instructions for Use to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose. Trividia Health will notify users of additional mitigation strategies as needed.

The system displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error. As currently written, the instructions could potentially lead to a delay in treatment if the user does not seek medical attention immediately when they receive an E-5 error code and are experiencing symptoms of high glucose. A delay in treatment may result in serious adverse health consequences or death, especially for users with very high blood glucose levels.

Display	Reason	Action
	Very high blood glucose result (higher than 600 mg/dL), or Test Strip Error	WARNING!! Retest with a new test strip. If the error persists and you have symptoms such as fatigue, excess urination, thirst or blurry vision, seek medical attention immediately. If you are not experiencing symptoms, retest with a new test strip. If the error persists, call 1-800-803-6025, Monday - Friday, 8AM-8PM EST for assistance.

What to do:

You may continue to use the TRUE METRIX® Products. Products are not to be returned or replaced. If you have any questions, please call Trividia Health Customer Care Department toll-free at 1-888-835-2723 Monday-Friday 8AM-8PM EST (excluding holidays) or e-mail trividia0126CC@trividiahealth.com or visit http://www.trividiahealth.com/E-5productnotice.