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Lifescan, Inc.

Last updated May 25, 2026

Information

Country: US
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EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 153409313

Catalogue (42)

Device	Model / Reference	Registries	Class	Status
OneTouch Ultra	024-391	FDA UDI	Class II	Active
OneTouch Ultra Blue Test Strips	024-273	FDA UDI	Class II	Active
One Touch Profile Complete Diabetes Tracking System	K950727	FDA 510(k)	Class II	Active
One Touch Ii Meter	K895911	FDA 510(k)	Class II	Active
Modification To One Touch Ultra Blood Glucose Monitoring System	K062195	FDA 510(k)	Class II	Active
Onetouch Vita Blood Glucose Monitoring System	K082513	FDA 510(k)	Class II	Active
Onetouch Ultralink Blood Glucose Monitoring System	K073231	FDA 510(k)	Class II	Active
Onetouch Ultramini Blood Glucose Monitoring System	K061118	FDA 510(k)	Class II	Active
One Touch Verio Blood Glucose Monitoring System	K093745	FDA 510(k)	Class II	Active
Glucoscan Test Strips	K822697	FDA 510(k)	Class II	Active
Surestep Blood Glucose Monitoring System	K984261	FDA 510(k)	Class II	Active
Saturn Blood Glucose Monitoring Test Strip	K001441	FDA 510(k)	Class II	Active
One Touch Ii Hospital Blood Glucose Monitoring System	K974451	FDA 510(k)	Class II	Active
Rubicon Prothrombin Time Monitoring System	K001699	FDA 510(k)	Class II	Active
Single (specified) Analyte Control (assayed)	K894804	FDA 510(k)	Class I	Active
One Touch Basic/Profile/One Touch Ii Test Strips	K031472	FDA 510(k)	Class II	Active
Mpx System, Glucose Test System	K864322	FDA 510(k)	Class II	Active
Lifescan Surestep Pro Glucose Control/Linearity Solutions	K971014	FDA 510(k)	Class I	Active
One Touch Ii Hospital Blood Glucose Monitoring System	K950816	FDA 510(k)	Class II	Active
Onetouch Select Blood Glucose Monitoring System	K072543	FDA 510(k)	Class II	Active
One Touch Ultrasmart Blood Glucose Monitoring System	K021819	FDA 510(k)	Class II	Active
Glucoscan Test Strips	K810993	FDA 510(k)	Class II	Active
Symphony Meter Remote	K082590	FDA 510(k)	Class II	Active
Gilucochek Reflectance Meter	K810665	FDA 510(k)	Class I	Active
Suresteppro/Surestepflexx Professional Blood Glucose Management System	K023194	FDA 510(k)	Class II	Active
One Touch Ii Hospital Blood Glucose Monitoring System Data Dock	K972473	FDA 510(k)	Class II	Active
One Touch(r) Ii Hospital Blood Glucose Monit Syst	K913357	FDA 510(k)	Class II	Active
One Touch Iib Blood Glucose Meter	K922888	FDA 510(k)	Class II	Active
Surestep Hospital Blood Glucose Monitoring System	K023832	FDA 510(k)	Class II	Active
Glucoscan Controls	K822698	FDA 510(k)	Class I	Active
Glucoscan Meter Model Ii	K822699	FDA 510(k)	Class II	Active
Surestep Pro Blood Glucose Monitoring System	K970556	FDA 510(k)	Class II	Active
One Touch Ultra And One Touch Induo Blood Glucose Monitoring Systems	K024194	FDA 510(k)	Class II	Active
Lifescan Surestep Blood Glucose Monitoring System	K942455	FDA 510(k)	Class II	Active
Onetouch Reveal Diabetes Management Application	K120558	FDA 510(k)	Class II	Active
Onetouch Zoom Diabetes Management Program	K081318	FDA 510(k)	Class II	Active
Harmony Inr Monitoring System	K022922	FDA 510(k)	Class II	Active
In Touch Diabetes Management Software	K984527	FDA 510(k)	Class II	Active
Onetouch Profile Blood Glucose Monitoring System	K021943	FDA 510(k)	Class II	Active
Onetouch Ultra, Induo And Ultrasmart Blood Glucose Monitoring System	K043197	FDA 510(k)	Class II	Active
Surestep Blood Glucose Monitoring System	K022724	FDA 510(k)	Class II	Active
Onetouch Ultra 2 Blood Glucose Monitoring System	K053529	FDA 510(k)	Class II	Active

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FDA Recalls (27)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 11, 2013	Z-1074-2013	—	terminated	The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE.
Feb 25, 2013	Z-1129-2013	—	terminated	When OneTouch Ultra and OneTouch Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.
Feb 25, 2013	Z-1130-2013	—	terminated	When OneTouch Ultra and OneTouch Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.
Feb 21, 2012	Z-1359-2012	—	terminated	An error was discovered in the OneTouch IQ meter software so that the meter turns itself off when a user attempts to view results in the "Results Log" when the log has 256 or a multiple of 256 items to display.
May 27, 2011	Z-2835-2011	—	terminated	Individuals attempting to remove a lancet from the OneTouch Delica lancing device without following instructions for use may experience an accidental needle stick.
Feb 24, 2010	Z-2027-2010	—	terminated	Products may provide inaccurate results at readings over 400 mg/dL
Feb 24, 2010	Z-2028-2010	—	terminated	Products may provide inaccurate results at readings over 400 mg/dL
Jan 7, 2010	Z-2639-2010	—	terminated	One Touch Ultra Test Strip products may actually contain a different product, One Touch Select strips.
Nov 25, 2008	Z-1070-2009	—	terminated	Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.
Sep 19, 2008	Z-0004-2009	—	terminated	Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low results.
Dec 18, 2007	Z-1317-2008	—	terminated	Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.
Mar 30, 2007	Z-1165-2007	—	terminated	Lancet tip may not fully retract and cause needle stick and exposure to used lancets.
Mar 22, 2007	Z-1042-2007	—	terminated	Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may produce inaccurately high or low blood glucose test results or error message readings.
Sep 29, 2006	Z-0452-2007	—	terminated	Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
Sep 29, 2006	Z-0453-2007	—	terminated	Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
Nov 1, 2005	Z-0435-06	—	terminated	Product may be defective and may give low inaccurate glucose results.
Oct 19, 2005	Z-0273-06	—	terminated	Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips.
Oct 11, 2005	Z-0271-06	—	terminated	In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks.
Oct 10, 2005	Z-0272-06	—	terminated	Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters
Sep 9, 2005	Z-0101-06	—	terminated	The LCD of the OneTouch SureStep Meter may display incorrectly, resulting in missing segments on the display. This display failure may result in patients misreading the blood glucose result, or cause a delay in test interpretation, and could cause delays or mistreatment.
Jun 9, 2005	Z-0980-05	—	terminated	Meter labeling (Owner's Booklet and Quick Reference Guide) is incorrect as it indicates that the meter displays the message 'Do you need a snack' for glucose values between 20 and 70 mg/dL; whereas the OneTouch UltraSmart meter displays the message, 'Do you need a snack?' for glucose values from 20 through 59 mg/dL.
Apr 11, 2005	Z-0821-05	—	terminated	User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
Apr 11, 2005	Z-0823-05	—	terminated	User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
Apr 11, 2005	Z-0822-05	—	terminated	User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
Nov 21, 2003	Z-1596-05	—	terminated	LifeScan brand OneTouch Ultra Meter - Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)--mg/dL versus mmol/L. This error has the potential to lead to acute hyperglycemic complications if the user fails to realize that 18mg/dL of glucose is equal to 1 (one) mmol/L.
Nov 17, 2003	Z-0887-05	—	terminated	A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.
Jan 13, 2003	Z-0630-03	—	terminated	The Test Strips have manufacturing errors, in that the 'Confirmation Dot' is off-center or split in half, and defective bottle Cap.