Lifescan, Inc.
Malvern, PA, US
Lifescan, Inc. appears in FDA device records in Malvern, PA. FDA records list 42 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 27 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 42 510(k) clearances for Lifescan, Inc. between 1981 and 2013. The busiest year on record is 2002, with 6. The most recent is 2013, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 2 |
| 1982 | 3 |
| 1987 | 1 |
| 1989 | 2 |
| 1991 | 1 |
| 1992 | 2 |
| 1995 | 3 |
| 1997 | 3 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 6 |
| 2003 | 2 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 4 |
| 2011 | 1 |
| 2013 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K132618 | ONETOUCH REVEAL | MRZ | Substantially Equivalent | |
| K120558 | ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION | NBW | Substantially Equivalent | |
| K093745 | ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K082590 | SYMPHONY METER REMOTE | LZG | Substantially Equivalent | |
| K082513 | ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K081318 | ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM | NBW | Substantially Equivalent | |
| K073231 | ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K072543 | ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K062195 | MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K061118 | ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K053529 | ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K043197 | ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K031472 | ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS | CGA | Substantially Equivalent | |
| K024194 | ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS | NBW | Substantially Equivalent | |
| K023832 | SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K023194 | SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM | CGA | Substantially Equivalent | |
| K022922 | HARMONY INR MONITORING SYSTEM | GJS | Substantially Equivalent | |
| K022724 | SURESTEP BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K021819 | ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K021943 | ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K001699 | RUBICON PROTHROMBIN TIME MONITORING SYSTEM | GJS | Substantially Equivalent | |
| K001441 | SATURN BLOOD GLUCOSE MONITORING TEST STRIP | CGA | Substantially Equivalent | |
| K984261 | SURESTEP BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K984527 | IN TOUCH DIABETES MANAGEMENT SOFTWARE | CGA | Substantially Equivalent | |
| K974451 | ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K972473 | ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK | CGA | Substantially Equivalent | |
| K970556 | SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K971014 | LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS | JJX | Substantially Equivalent | |
| K950816 | ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K950727 | ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM | CGA | Substantially Equivalent | |
| K942455 | LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K923544 | ONE TOUCH TEST STRIPS | CGA | Substantially Equivalent | |
| K922888 | ONE TOUCH IIB BLOOD GLUCOSE METER | CGA | Substantially Equivalent | |
| K913357 | ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST | CGA | Substantially Equivalent | |
| K895911 | ONE TOUCH II METER | CGA | Substantially Equivalent | |
| K894804 | SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED) | JJX | Substantially Equivalent | |
| K864322 | MPX SYSTEM, GLUCOSE TEST SYSTEM | CGA | Substantially Equivalent | |
| K822699 | GLUCOSCAN METER MODEL II | CGA | Substantially Equivalent | |
| K822698 | GLUCOSCAN CONTROLS | JJX | Substantially Equivalent | |
| K822697 | GLUCOSCAN TEST STRIPS | CGA | Substantially Equivalent | |
| K810993 | GLUCOSCAN TEST STRIPS | CGA | Substantially Equivalent | |
| K810665 | GILUCOCHEK REFLECTANCE METER | JJQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009698388 | 2939301 | Lifescan, Inc. | 75 Valley Stream Parkway, Malvern, PA 19355 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 27| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1074-2013 | 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. | Class I | Terminated | |
| Z-1130-2013 | 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. | Class II | Terminated | |
| Z-1129-2013 | 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. | Class II | Terminated | |
| Z-1359-2012 | 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. | Terminated | ||
| Z-2835-2011 | 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. | Terminated | ||
| Z-2028-2010 | 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 | Terminated | ||
| Z-2027-2010 | 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 | Terminated | ||
| Z-2639-2010 | 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. | Terminated | ||
| Z-1070-2009 | 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. | Terminated | ||
| Z-0004-2009 | 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. | Terminated | ||
| Z-1317-2008 | LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037. | Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily. | Terminated | ||
| Z-1165-2007 | One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200 | Lancet tip may not fully retract and cause needle stick and exposure to used lancets. | Terminated | ||
| Z-1042-2007 | OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07, 020-244-07, 020-963-01) | 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. | Terminated | ||
| Z-0453-2007 | LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037 | Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results. | Terminated | ||
| Z-0452-2007 | LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037 | Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results. | Terminated | ||
| Z-0435-06 | LifeScan OneTouch Ultra Test strips, lot number 2528640 | Product may be defective and may give low inaccurate glucose results. | Terminated | ||
| Z-0273-06 | LifeScan brand OneTouch Ultra Test strips, 25 strips per vial | Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips. | Terminated | ||
| Z-0271-06 | LifeScan OneTouch SureSoft Lancing Device, single use lancing device. | In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks. | Terminated | ||
| Z-0272-06 | LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter | Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters | Terminated | ||
| Z-0101-06 | Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037 | 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. | Terminated | ||
| Z-0980-05 | LifeScan brand One Touch UltraSmart Meter Owners Booklet AW 060-788-01A; All One Touch UltraSmart Meters shipped with OneTouch UltraSmart Owner''s Booklet AW 060-788-01A are affected by this Field Correction. | 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. | Terminated | ||
| Z-0823-05 | LifeScan Brand InDuo Blood Glucose Meter | 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. | Terminated | ||
| Z-0822-05 | LifeScan brand OneTouch FastTake Blood Glucose Meter | 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. | Terminated | ||
| Z-0821-05 | LifeScan brand OneTouch Ultra Blood Glucose Meter | 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. | Terminated | ||
| Z-1596-05 | LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain