Elevated risk U.S. Food and Drug Administration

Abbott FreeStyle Libre® 3 sensors recall: Sensors may provide incorrect high glucose readings

Recall published 2+ years ago

Sensors may provide incorrect high glucose readings

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
July 24, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Abbott
Product type
Medical devices

Products covered by this recall

FreeStyle Libre® 3 sensors

What the company announced

↵

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 www.FreeStyleConfirm.com 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

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.

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.

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.

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

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).

How to Identify Lot or Serial Number

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.

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 www.FreeStyleConfirm.com.

Checking if the Sensor is Affected

If the consumer’s product lot number is listed above, they need to visit www.FreeStyleConfirm.com , 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.

"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."

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.

Consumers can visit www.FreeStyleConfirm.com 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.

About Abbott:

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 www.abbott.com and on LinkedIn , Facebook , Instagram , X and YouTube .

Abbott Media:

Katie Walker

[email protected]

Lindsy Delco

[email protected]

Abbott Financial:

Mike Comilla

[email protected]

Important Safety Information:

Product for prescription only, for Important Safety Information, please visit https://www.freestyle.abbott/us-en/safety-information.html .

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • T60001948 T60001966 T60001969

Model or item number

On the rating label, the box or the instruction sheet.

  • July 2

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Abbott — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Remedy named in the notice: Consumers can visit www.FreeStyleConfirm.com to see if their sensors are affected and to get a replacement at no charge

Company contact: Abbott — Consumers: Customer Service, 1-833-815-4273 — Media: Katie Walker, Lindsy Delco, Mike Comilla, Abbott Financial, [email protected], [email protected], [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Abbott medical devices recalled?

Sensors may provide incorrect high glucose readings 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code T60001948 T60001966 T60001969; model number July 2. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

The notice says: Consumers can visit www.FreeStyleConfirm.com to see if their sensors are affected and to get a replacement at no charge

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