Abbott Diabetes Care, Inc. recalls FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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