Lifescan Inc
FDA Regulatory Profile
Lifescan Inc appears in FDA public data with 3 recalls — including 1 Class I (most serious) —, 42 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1074-2013, Class I) was initiated on March 11, 2013. Its most recent 510(k) clearance was granted on December 16, 2013.
Summary
- Total Recalls
- 3 (1 Class I)
- 510(k) Clearances
- 42
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1074-2013 | Class I | All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter | March 11, 2013 |
| Z-1129-2013 | Class II | LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. | February 25, 2013 |
| Z-1130-2013 | Class II | LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902. Testing of Blood | February 25, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K132618 | ONETOUCH REVEAL | December 16, 2013 |
| K120558 | ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION | February 7, 2013 |
| K093745 | ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM | February 11, 2011 |
| K082590 | SYMPHONY METER REMOTE | December 17, 2008 |
| K082513 | ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM | October 22, 2008 |
| K081318 | ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM | June 9, 2008 |
| K073231 | ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM | April 18, 2008 |
| K072543 | ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM | October 5, 2007 |
| K062195 | MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | August 16, 2006 |
| K061118 | ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM | May 19, 2006 |
| K053529 | ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM | January 17, 2006 |
| K043197 | ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM | May 20, 2005 |
| K031472 | ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS | August 5, 2003 |
| K024194 | ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS | February 7, 2003 |
| K023832 | SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM | December 13, 2002 |
| K023194 | SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM | October 24, 2002 |
| K022922 | HARMONY INR MONITORING SYSTEM | September 30, 2002 |
| K022724 | SURESTEP BLOOD GLUCOSE MONITORING SYSTEM | September 12, 2002 |
| K021819 | ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM | August 23, 2002 |
| K021943 | ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM | June 28, 2002 |