Lifescan, Inc.
Medical device manufacturer in Wayne, PA.
42510(k) clearances
0PMA approvals
15recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K132618 | Onetouch RevealMRZ · Traditional | 12/16/2013SE |
| K120558 | Onetouch Reveal Diabetes Management ApplicationNBW · Traditional | 02/07/2013SE |
| K093745 | One Touch Verio Blood Glucose Monitoring SystemNBW · Traditional | 02/11/2011SE |
| K082590 | Symphony Meter RemoteLZG · Traditional | 12/17/2008SE |
| K082513 | Onetouch Vita Blood Glucose Monitoring SystemNBW · Special | 10/22/2008SE |
| K081318 | Onetouch Zoom Diabetes Management ProgramNBW · Special | 06/09/2008SE |
| K073231 | Onetouch Ultralink Blood Glucose Monitoring SystemNBW · Traditional | 04/18/2008SE |
| K072543 | Onetouch Select Blood Glucose Monitoring SystemNBW · Special | 10/05/2007SE |
| K062195 | Modification to One Touch Ultra Blood Glucose Monitoring SystemNBW · Special | 08/16/2006SE |
| K061118 | Onetouch Ultramini Blood Glucose Monitoring SystemNBW · Special | 05/19/2006SE |
| K053529 | Onetouch Ultra 2 Blood Glucose Monitoring SystemNBW · Special | 01/17/2006SE |
| K043197 | Onetouch Ultra, Induo and Ultrasmart Blood Glucose Monitoring SystemCGA · Traditional | 05/20/2005SE |
| K031472 | One Touch Basic/Profile/One Touch II Test StripsCGA · Traditional | 08/05/2003SE |
| K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsNBW · Traditional | 02/07/2003SE |
| K023832 | Surestep Hospital Blood Glucose Monitoring SystemNBW · Special | 12/13/2002SE |
| K023194 | Suresteppro/Surestepflexx Professional Blood Glucose Management SystemCGA · Special | 10/24/2002SE |
| K022922 | Harmony Inr Monitoring SystemGJS · Special | 09/30/2002SE |
| K022724 | Surestep Blood Glucose Monitoring SystemNBW · Special | 09/12/2002SE |
| K021819 | One Touch Ultrasmart Blood Glucose Monitoring SystemNBW · Traditional | 08/23/2002SE |
| K021943 | Onetouch Profile Blood Glucose Monitoring SystemCGA · Traditional | 06/28/2002SE |
| K001699 | Rubicon Prothrombin Time Monitoring SystemGJS · Traditional | 05/15/2001SE |
| K001441 | Saturn Blood Glucose Monitoring Test StripCGA · Traditional | 12/18/2000SE |
| K984261 | Surestep Blood Glucose Monitoring SystemCGA · Traditional | 05/21/1999SE |
| K984527 | In Touch Diabetes Management SoftwareCGA · Traditional | 04/29/1999SE |
| K974451 | One Touch II Hospital Blood Glucose Monitoring SystemCGA · Traditional | 01/26/1998SE |
| K972473 | One Touch II Hospital Blood Glucose Monitoring System Data DockCGA · Traditional | 12/16/1997SE |
| K970556 | Surestep Pro Blood Glucose Monitoring SystemCGA · Traditional | 05/12/1997SE |
| K971014 | Lifescan Surestep Pro Glucose Control/Linearity SolutionsJJX · Traditional | 04/23/1997SE |
| K950816 | One Touch II Hospital Blood Glucose Monitoring SystemCGA · Traditional | 07/03/1995SE |
| K950727 | One Touch Profile Complete Diabetes Tracking SystemCGA · Traditional | 06/01/1995SE |
| K942455 | Lifescan Surestep Blood Glucose Monitoring SystemCGA · Traditional | 03/24/1995SE |
| K923544 | One Touch Test StripsCGA · Traditional | 12/03/1992SE |
| K922888 | One Touch Iib Blood Glucose MeterCGA · Traditional | 09/15/1992SE |
| K913357 | One Touch(R) II Hospital Blood Glucose Monit SystCGA · Traditional | 11/07/1991SE |
| K895911 | One Touch II MeterCGA · Traditional | 11/08/1989SE |
| K894804 | Single (Specified) Analyte Control (Assayed)JJX · Traditional | 09/28/1989SE |
| K864322 | MPX System, Glucose Test SystemCGA · Traditional | 02/25/1987SE |
| K822699 | Glucoscan Meter Model IICGA · Traditional | 11/05/1982SE |
| K822698 | Glucoscan ControlsJJX · Traditional | 09/30/1982SE |
| K822697 | Glucoscan Test StripsCGA · Traditional | 09/30/1982SE |
| K810993 | Glucoscan Test StripsCGA · Traditional | 04/29/1981SE |
| K810665 | Gilucochek Reflectance MeterJJQ · Traditional | 04/17/1981SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1074-2013 Class I | All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio…The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of… | 03/11/2013Terminated |
| Z-1130-2013 Class II | LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902. Testing…When OneTouch Ultra and OneTouch Select test strips are tested with Ultra and Select control solution the… | 02/25/2013Terminated |
| Z-1129-2013 Class II | LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808…When OneTouch Ultra and OneTouch Select test strips are tested with Ultra and Select control solution the… | 02/25/2013Terminated |
| Z-1359-2012 | OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose…An error was discovered in the OneTouch IQ meter software so that the meter turns itself off when a user… | 02/21/2012Terminated |
| Z-2835-2011 | OneTouch Delica Lancing Device; LifeScan Inc., Milpitas, CA Testing of Blood Glucose…Individuals attempting to remove a lancet from the OneTouch Delica lancing device without following… | 05/27/2011Terminated |
| Z-2028-2010 | OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose…Products may provide inaccurate results at readings over 400 mg/dL | 02/24/2010Terminated |
| Z-2027-2010 | OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood…Products may provide inaccurate results at readings over 400 mg/dL | 02/24/2010Terminated |
| Z-2639-2010 | One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by…One Touch Ultra Test Strip products may actually contain a different product, One Touch Select strips. | 01/07/2010Terminated |
| Z-1070-2009 | OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with…Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in… | 11/25/2008Terminated |
| Z-0004-2009 | One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc…Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low results. | 09/19/2008Terminated |
| Z-1317-2008 | LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for…Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease… | 12/18/2007Terminated |
| Z-1165-2007 | One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft…Lancet tip may not fully retract and cause needle stick and exposure to used lancets. | 03/30/2007Terminated |
| Z-1042-2007 | OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose…Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had… | 03/22/2007Terminated |
| Z-0453-2007 | LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50…Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results. | 09/29/2006Terminated |
| Z-0452-2007 | LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50…Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results. | 09/29/2006Terminated |