FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring

FDA device recall Z-1275-2023 · posted 2023-04-06 · Open, Classified

Recall details

Recalling firm

Abbott Diabetes Care, Inc.

Reason for recall

Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.

Action taken

On 02/13/2023, correction notices were mailed or emailed to customers, health care professionals, and distribution partners who were asked to do the following: To determine if the Reader needs to be replaced, answer these questions: Does Reader appear damaged, cracked, or swollen? Has Reader been too hot to hold? Is it no longer able to hold a charge? If NO to all, perform a Reader Test. See www.FreeStyleBattery.com If yes or if the test failed, discontinue use and call Customer Service for replacement. - Don't expose the Reader, power adapter or yellow USB cable to liquids. - Store the Reader between -4 F and 140 F. - Avoid getting dust, dirt, blood, control solution, water, bleach, or any other substance in the test strip or USB port. - Check USB port and make sure it is dry and free of debris. - Use only the Abbott provided power adapter and yellow USB cable that came with your Reader and check they are free from damage. - Ensure you can access the power adapter and quickly disconnect it to prevent the potential risk of electrical shock. - Don't force or bend the end of the yellow USB cable into the Reader's USB port. - If the Reader is dropped or subjected to impact, perform a Reader Test to confirm it is still working properly. Customers are asked to acknowledge they have read and understood the actions contained in the letter by clicking the link or scanning the QR code. Health Care Professions were asked to ask their patients the questions above. Distribution Partners were asked to forward the correction notice and response form to customers. Customers with questions can contact Customer Service at 1-855-632-8658, available 7 days a week from 8AM to 8PM Eastern Time excluding major holidays.

Root cause

Device Design

Status

Open, Classified

Product code

QLG

Quantity affected

1,534,532

Distribution

U.S. Nationwide.

Date initiated

2023-02-13

Date posted

2023-04-06

Location

Alameda, CA

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