Reported Aug 23, 2023 · Ongoing
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Abbott Diabetes Care, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Diabetes Care, Inc. · 1360 S Loop Rd · Alameda, CA · 94502-7000
Is this the product you have?
- FreeStyle Libre 2 Readers
- REF
71951-01 and 71953-01used with FreeStyle Libre 2 System
- Lot codes and dates
2 of 2 products · 423 lot codes
Recalled lot codes, grouped by product number REF UDI-DI Lots 71951-0135759980500502A289D03B082D02B082D02B109D03B251D04B251D01C073D01C084D02C087D01C143D03C152D03C166D01C174D03C222D01C256D02C313D01D018D02D093D02D129D
71953-0135759980300101A198D02A198D03A198D04A198D05A198D01A202D04A202D01A204D02A203D02A205D03A205D01A211D02A211D03A210D02A212D04A218D05A218D06A218D01A219D04A225D05A225D01A231D03A231D02A232D06A232D02A240D02A248D01A259D01A260D04A262D03A266D01A267D02A268D03A268D02A280D01A281D01A283D02A283D01A290D02A297D02A298D03A296D02A303D02A304D04A325D01A328D03A325D02A340D03A344D02A351D03A350D01A352D03A352D02A358D01A364D02A363D01B007F02B007F01B008F01B011F03B012F01B012F01B014F05B013F01B015F04B013F02B013F11B021F02B034F02B035F04B034F04B035F06B034F07B034F02B036F05B035F01B036F01B039F03B039F03B036F03B041F05B041F02B042F03B043F02B046F05B043F06B046F09B046F01B071F05B071F06B074F04B074F02B076F05B075F01B077F05B076F02B078F05B078F02B081F02B082F04B082F02B083D05B082D03B109D02B203D03B203D01B205D01B207D01B208D02B208D02B211D02B216D02B229D01B288D02B289D01B289D02B305D01B306F02B306F01B306D02B308F03B306F01B308F01B309F01B309D01B310D02B312D01B313D03B312D03B313D05B322F07B322F01B323F01B326F06B322F01B305D01B327F03B326F04B326F02B328F01B308D01B333D01B334D01B335F03B335F02B333D01B336F02B336F01B337F02B337F01B302F01B340F02B340F03B302F04B301F01B337D01B341F02B341F01B341D02B341D01B342F02B342F02B343F01B343F04B302F02B344F06B349F03B351D04B352D04B354D02B356D01B356D04B356D05B356D01B362D02B362D02B363D01C006D03C005D02C005D02C010D01C011D01C012D03C013D02C013D02C025F03C028F01C028F02C031F03C031F01C034F02C032F01C074D03C074D02C073D02C074D03C075D01C075D02C080D02C112D03C117D03C123D03C126D02C130D03C129D02C133D03C133D01C133D01C136D02C136D01C137D01C138D04C138D01C140D02C140D03C140D02C143D01C144D02C145D05C146D01C146D01C159D03C159D01C161D03C165D05C165D02C172D01C181D02C181D01C182D01C186D01C188D02C188D01C194D02C193D03C196D03C199D05C199D01C201D02C199D03C207D01C207D01C209D02C208D03C213D02C223D01C223D01C224D02C224D01C227D01C228D02C229D03C224D02C236D01C237D03C236D02C237D03C238D04C241D01C242D01C243D03C242D02C242D02C243D04C243D01C245D02C245D01C249D02C250D03C251D02C255D03C256D01C257D02C256D02C257D03C257D02C262D02C265D01C266D03C270D08C271D01C272D01C276D01C273D04C276D02C278D03C279D01C283D02C287D04C292D02C294D03C294D06C292D01C298D01C299D02C298D01C305D02C305D03C305D01C307D01C308D01C313D02C312D01C317D01C318D03C320D02C321D01C322D01C325D02C325D01C326D01C332D01C327D01C334D02C334D04C334D01C340D02C340D01C341D03C340D01C346D02C355D01D010D01D011D02D011D01D012D02D018D02D017D02D023D02D028D02D019D03D024D01D025D02D025D01D027D03D027D01D033D03D034D04D034D05D033D01D040D02D040D02D038D06D055D03D041D02D045D02D053D03D058D02D056D02D060D03D067D04D068D03D065D02D065D02D066D02D069D01D072D03D069D02D072D01D076D02D075D03D075D01D095D03D083D01D081D02D095D02D081D02D082D03D080D02D087D06D103D01D102D02D107D01D107D01D104D03D107D02D104D01D111D01D115D02D115D02D116D03D115D01D128D01D129D05D130D04D125D02D128D03D136D02D136D03D142D01D139D03D144D02D125D01D150D03D151D02D151D03D152D01D156D02D157D02D160D02D156D01D159D01D177D02D177D
- Amount recalled
- 1,722,645
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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