Lifescan, Inc.
FDA adverse event reports naming Lifescan, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: LIFESCAN, INC..
- Total reports
- 59,840
- Deaths
- 23
- Injuries
- 11,667
- Malfunctions
- 47,823
Reports per year
Source: FDA adverse event reports by year received, 2007–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Hexokinase, GlucoseCFR29,419
- System, Test, Blood Glucose, Over The CounterNBW25,608
- Glucose Oxidase, GlucoseCGA2,429
- Sensor, Glucose, InvasiveMDS2,108
- Single Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureFMK187
- Glucose Dehydrogenase, GlucoseLFR40
- Product code ------17
- Pump, InfusionFRN11
- Product code MBWMBW6
- Pump, Infusion, InsulinLZG2
Recent recalls
- 2013-04-17TerminatedNonconforming Material/Component
LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
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.
- 2013-04-17TerminatedNonconforming Material/Component
LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
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.
- 2013-04-12TerminatedSoftware design
All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch VerioIQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE.
- 2012-04-02TerminatedSoftware design
OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Starter Kit; One Touch Verio IQ Blood Glucose Monitoring Warranty Kit. Distributed by : LifeScan, Inc. Milpitas, CA 95035 for: LifeScan Europe Division of Cilag GmBH International 6300 Zug Switzerland Meter made in China. Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood.
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.
- 2011-07-15TerminatedOther
OneTouch Delica Lancing Device; LifeScan Inc., Milpitas, CA Testing of Blood Glucose Levels
Individuals attempting to remove a lancet from the OneTouch Delica lancing device without following instructions for use may experience an accidental needle stick.
- 2010-10-01TerminatedMixed-up of materials/components
One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA.
One Touch Ultra Test Strip products may actually contain a different product, One Touch Select strips.
- 2010-07-17TerminatedOther
OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in 100 count and 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico Medical device for quantitative measurement of glucose in whole blood for use in home settings (SureStep).
Products may provide inaccurate results at readings over 400 mg/dL
- 2010-07-17TerminatedOther
OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose Meters, in 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico Medical device for quantitative measurement of glucose in whole blood for use in hospital and clinical settings. The product is also for use in quantitative measurement of glucose in venous, capillary, arterial and neonatal whole blood samples. This system can also be used by lay users at home.
Products may provide inaccurate results at readings over 400 mg/dL
- 2009-03-17TerminatedProcess design
OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA
Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.
- 2008-11-21TerminatedProcess control
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low results.
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