FreeStyle Libre 2 Readers recall
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Why was FreeStyle Libre 2 Readers recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
- Recalling firm
- Abbott Diabetes Care, Inc.
- Quantity
- 1,722,645
- Distribution
- US Nationwide distribution in the states of CA, FL, MI, NY, OH, TX, UT, VA.
- Recall date
- August 23, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)