Abbott Diabetes Care FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The recall — FDA Z-1020-2026
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Overview of recall records associated with Abbott Diabetes Care, Inc., including dates, categories and classifications where available.
Classification mix: Class I: 8, Class II: 5.
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating…
If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive…
If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor"…
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…
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…
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…
Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared…
Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared…
Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared…
This page summarizes recall records in which the official source identifies Abbott Diabetes Care, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.