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Lifescan Inc

27 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 0214 recall (Z-1129-2013)Lifescan Inc2013-04-17
LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902. Testing of recall (Z-1130-2013)Lifescan Inc2013-04-17
All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ recall (Z-1074-2013)Lifescan Inc2013-04-12
OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose IQ recall (Z-1359-2012)Lifescan Inc2012-04-02
OneTouch Delica Lancing Device; LifeScan Inc., Milpitas, CA Testing of Blood Glucose Level recall (Z-2835-2011)Lifescan Inc2011-07-15
One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by L recall (Z-2639-2010)Lifescan Inc2010-10-01
OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood G recall (Z-2027-2010)Lifescan Inc2010-07-17
OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose Me recall (Z-2028-2010)Lifescan Inc2010-07-17
OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureSt recall (Z-1070-2009)Lifescan Inc2009-03-17
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpita recall (Z-0004-2009)Lifescan Inc2008-11-21
LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTou recall (Z-1317-2008)Lifescan Inc2008-04-08
One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospi recall (Z-1165-2007)Lifescan Inc2007-08-16
OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring recall (Z-1042-2007)Lifescan Inc2007-07-13
LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips recall (Z-0452-2007)Lifescan Inc2007-01-05
LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 s recall (Z-0453-2007)Lifescan Inc2007-01-05
LifeScan OneTouch Ultra Test strips, lot number 2528640 recall (Z-0435-06)Lifescan Inc2006-01-24
LifeScan OneTouch SureSoft Lancing Device, single use lancing device. recall (Z-0271-06)Lifescan Inc2005-12-08
LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter recall (Z-0272-06)Lifescan Inc2005-12-08
LifeScan brand OneTouch Ultra Test strips, 25 strips per vial recall (Z-0273-06)Lifescan Inc2005-12-08
Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is distributed by recall (Z-0101-06)Lifescan Inc2005-10-28
LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distri recall (Z-1596-05)Lifescan Inc2005-09-29
LifeScan brand One Touch UltraSmart Meter Owners Booklet AW 060-788-01A; All One Touch Ult recall (Z-0980-05)Lifescan Inc2005-07-13
LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number recall (Z-0887-05)Lifescan Inc2005-06-14
LifeScan brand OneTouch Ultra Blood Glucose Meter recall (Z-0821-05)Lifescan Inc2005-05-17
LifeScan brand OneTouch FastTake Blood Glucose Meter recall (Z-0822-05)Lifescan Inc2005-05-17
LifeScan Brand InDuo Blood Glucose Meter recall (Z-0823-05)Lifescan Inc2005-05-17
OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test S recall (Z-0630-03)Lifescan Inc2003-03-12

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Every clearance here is in the API, with alerts when new ones post.