Abbott Laboratories Medisense Products Boots Glucose Monitoring System Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boots Glucose Monitoring System Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Brand
Abbott Laboratories Medisense Products
Lot Codes / Batch Numbers
All lot numbers are included in this recall.
Products Sold
All lot numbers are included in this recall.
Abbott Laboratories Medisense Products is recalling Boots Glucose Monitoring System Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South due to User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
Recommended Action
Per FDA guidance
The firm has undertaken a field correction to notify their customers of the potential for the units of measure to be changed. The firm plans to (1) include a flyer in all Precision Xtra and FreeStyle meter kits to reinforce current labeling regarding units of measure and update the Frequently Asked Questions section of the website to reinforce the units of measure change, (2) Lock out the units of measure in new production meters to eliminate potential to change the units of measure settings, update the meter kits with a flyer to override the section of the manual indicating that the units of measure are changeable, and change the product insert in glucose test strips to indicate which units of measure are appropriate for the user and (3) update the labeling to indicate that the units of measure are not user configurable to eliminate the need for the flier.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026