Z-2414-2023Class II

FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System

Name: Z-2414-2023 FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Creator: Abbott Diabetes Care, Inc.
Published: 2023-07-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2023-07-12 / Open, Classified / root cause: software

FDA source

Abbott Diabetes Care, Inc. began a recall of FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System on 2023-07-12. FDA classified it as Class II and gives the reason as "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" message. If users don't have the...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2414-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-12
Posted: 2023-08-17
Recalling firm: Abbott Medical
Product: FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Product code: QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Reason for recall: 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" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results
Root cause tag: software
FDA root cause: Software Design Change
Action: On 7/12/23, correction notices were e-mailed or mailed to customers and distributors who were asked to do the following: If the "Incompatible Sensor" message is received when applying a new sensor and attempting it to start it with the Reader, follow these steps below. If previous Sensor retained: a) Wait 3 hours before scanning the previous sensor. While waiting, please use a blood glucose meter to check glucose. b) "Replace Sensor" should appear. c) Scan the new Sensor and "New Sensor Starting Up" screen should appear. If previous Sensor not retained: a) Users can use the free FreeStyle Libre 2 app to activate the new Sensor and get glucose data on the user's compatible smartphone. -The new Sensor that generated the "Incompatible Sensor" error message on the Reader can still be used with the app. -App can be download from the Apple App Store or Google Play Store. -To check smartphone compatibility, visit: https://www.freestyle.abbott/usen//products/freestyle-libre-app/compatibility.html b) Open the FreeStyle Libre 2 app c) Follow the instructions on the app to start the new Sensor. -Users can start the next Sensor with the Reader once a "Sensor Ended" is received. -Users can wait until the 14-day wear time for the previous Sensor has ended to activate the new Sensor with the Reader. The Reader Home Screen will indicate sensor wear days remaining. The Reader can be used as a blood glucose meter; this functionality isn't impacted by the Incompatible Sensor message. If not able to scan the previous Sensor and a compatible smartphone is not available, contact Customer Service at 1-855-632-8658 to receive further assistance. Additionally, contact Customer Service to report any adverse reactions or quality problems. Distributors should acknowledge receipt of the notice and provide the customer notice to all customers who were supplied Sensors since April 20, 2023.
Quantity in commerce: 1,722,645
Distribution: US Nationwide distribution in the states of CA, FL, MI, NY, OH, TX, UT, VA.
Product codes and lots: REF/UDI-DI/Lots: 71951-01/357599805005/02A289D, 03B082D, 02B082D, 02B109D, 03B251D, 04B251D, 01C073D, 01C084D, 02C087D, 01C143D, 03C152D, 03C166D, 01C174D, 03C222D, 01C256D, 02C313D, 01D018D, 02D093D, 02D129D; 71953-01/357599803001/01A198D, 02A198D, 03A198D, 04A198D, 05A198D, 01A202D, 04A202D, 01A204D, 02A203D, 02A205D, 03A205D, 01A211D, 02A211D, 03A210D, 02A212D, 04A218D, 05A218D, 06A218D, 01A219D, 04A225D, 05A225D, 01A231D, 03A231D, 02A232D, 06A232D, 02A240D, 02A248D, 01A259D, 01A260D, 04A262D, 03A266D, 01A267D, 02A268D, 03A268D, 02A280D, 01A281D, 01A283D, 02A283D, 01A290D, 02A297D, 02A298D, 03A296D, 02A303D, 02A304D, 04A325D, 01A328D, 03A325D, 02A340D, 03A344D, 02A351D, 03A350D, 01A352D, 03A352D, 02A358D, 01A364D, 02A363D, 01B007F, 02B007F, 01B008F, 01B011F, 03B012F, 01B012F, 01B014F, 05B013F, 01B015F, 04B013F, 02B013F, 11B021F, 02B034F, 02B035F, 04B034F, 04B035F, 06B034F, 07B034F, 02B036F, 05B035F, 01B036F, 01B039F, 03B039F, 03B036F, 03B041F, 05B041F, 02B042F, 03B043F, 02B046F, 05B043F, 06B046F, 09B046F, 01B071F, 05B071F, 06B074F, 04B074F, 02B076F, 05B075F, 01B077F, 05B076F, 02B078F, 05B078F, 02B081F, 02B082F, 04B082F, 02B083D, 05B082D, 03B109D, 02B203D, 03B203D, 01B205D, 01B207D, 01B208D, 02B208D, 02B211D, 02B216D, 02B229D, 01B288D, 02B289D, 01B289D, 02B305D, 01B306F, 02B306F, 01B306D, 02B308F, 03B306F, 01B308F, 01B309F, 01B309D, 01B310D, 02B312D, 01B313D, 03B312D, 03B313D, 05B322F, 07B322F, 01B323F, 01B326F, 06B322F, 01B305D, 01B327F, 03B326F, 04B326F, 02B328F, 01B308D, 01B333D, 01B334D, 01B335F, 03B335F, 02B333D, 01B336F, 02B336F, 01B337F, 02B337F, 01B302F, 01B340F, 02B340F, 03B302F, 04B301F, 01B337D, 01B341F, 02B341F, 01B341D, 02B341D, 01B342F, 02B342F, 02B343F, 01B343F, 04B302F, 02B344F, 06B349F, 03B351D, 04B352D, 04B354D, 02B356D, 01B356D, 04B356D, 05B356D, 01B362D, 02B362D, 02B363D, 01C006D, 03C005D, 02C005D, 02C010D, 01C011D, 01C012D, 03C013D, 02C013D, 02C025F, 03C028F, 01C028F, 02C031F, 03C031F, 01C034F, 02C032F, 01C074D, 03C074D, 02C073D, 02C074D, 03C075D, 01C075D, 02C080D, 02C112D, 03C117D, 03C123D, 03C126D, 02C130D, 03C129D, 02C133D, 03C133D, 01C133D, 01C136D, 02C136D, 01C137D, 01C138D, 04C138D, 01C140D, 02C140D, 03C140D, 02C143D, 01C144D, 02C145D, 05C146D, 01C146D, 01C159D, 03C159D, 01C161D, 03C165D, 05C165D, 02C172D, 01C181D, 02C181D, 01C182D, 01C186D, 01C188D, 02C188D, 01C194D, 02C193D, 03C196D, 03C199D, 05C199D, 01C201D, 02C199D, 03C207D, 01C207D, 01C209D, 02C208D, 03C213D, 02C223D, 01C223D, 01C224D, 02C224D, 01C227D, 01C228D, 02C229D, 03C224D, 02C236D, 01C237D, 03C236D, 02C237D, 03C238D, 04C241D, 01C242D, 01C243D, 03C242D, 02C242D, 02C243D, 04C243D, 01C245D, 02C245D, 01C249D, 02C250D, 03C251D, 02C255D, 03C256D, 01C257D, 02C256D, 02C257D, 03C257D, 02C262D, 02C265D, 01C266D, 03C270D, 08C271D, 01C272D, 01C276D, 01C273D, 04C276D, 02C278D, 03C279D, 01C283D, 02C287D, 04C292D, 02C294D, 03C294D, 06C292D, 01C298D, 01C299D, 02C298D, 01C305D, 02C305D, 03C305D, 01C307D, 01C308D, 01C313D, 02C312D, 01C317D, 01C318D, 03C320D, 02C321D, 01C322D, 01C325D, 02C325D, 01C326D, 01C332D, 01C327D, 01C334D, 02C334D, 04C334D, 01C340D, 02C340D, 01C341D, 03C340D, 01C346D, 02C355D, 01D010D, 01D011D, 02D011D, 01D012D, 02D018D, 02D017D, 02D023D, 02D028D, 02D019D, 03D024D, 01D025D, 02D025D, 01D027D, 03D027D, 01D033D, 03D034D, 04D034D, 05D033D, 01D040D, 02D040D, 02D038D, 06D055D, 03D041D, 02D045D, 02D053D, 03D058D, 02D056D, 02D060D, 03D067D, 04D068D, 03D065D, 02D065D, 02D066D, 02D069D, 01D072D, 03D069D, 02D072D, 01D076D, 02D075D, 03D075D, 01D095D, 03D083D, 01D081D, 02D095D, 02D081D, 02D082D, 03D080D, 02D087D, 06D103D, 01D102D, 02D107D, 01D107D, 01D104D, 03D107D, 02D104D, 01D111D, 01D115D, 02D115D, 02D116D, 03D115D, 01D128D, 01D129D, 05D130D, 04D125D, 02D128D, 03D136D, 02D136D, 03D142D, 01D139D, 03D144D, 02D125D, 01D150D, 03D151D, 02D151D, 03D152D, 01D156D, 02D157D, 02D160D, 02D156D, 01D159D, 01D177D, 02D177D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2414-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2414-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-23	2023-08-17

Product code QLG

K193371Class IIFreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. / cleared 2020-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)