FDA-Device2023-04-12Class I
FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
Abbott Diabetes Care, Inc.
Hazard
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.
Sold states
U.S. Nationwide.
Affected count
1,373,311
Manufactured in
1360 S Loop Rd, Alameda, CA, United States
Products
FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1274-2023Don't want to check this manually?
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