Onetouch Ultra, Induo and Ultrasmart Blood Glucose Monitoring System

• • Terminated Z-0435-06 FDA Unclassified (pre-2012) ·initiated 1 Nov 2005

  Product may be defective and may give low inaccurate glucose results.

• • Terminated Z-0273-06 FDA Unclassified (pre-2012) ·initiated 19 Oct 2005 ·on shared 510(k) K043197

  Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips.

• • Terminated Z-0272-06 FDA Unclassified (pre-2012) ·initiated 10 Oct 2005 ·on shared 510(k) K043197

  Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K043197 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Onetouch Reveal

  Class II

  FDA 510(k) K132618 Active Cleared 16 Dec 2013

• One Touch Profile Complete Diabetes Tracking System

  Class II

  FDA 510(k) K950727 Active Cleared 1 Jun 1995

• One Touch II Meter

  Class II

  FDA 510(k) K895911 Active Cleared 8 Nov 1989

• Modification to One Touch Ultra Blood Glucose Monitoring System Open recall

  Class II

  FDA 510(k) K062195 Active Cleared 16 Aug 2006

• Onetouch Vita Blood Glucose Monitoring System

  Class II

  FDA 510(k) K082513 Active Cleared 22 Oct 2008

• Onetouch Ultralink Blood Glucose Monitoring System

  Class II

  FDA 510(k) K073231 Active Cleared 18 Apr 2008

See all devices from Lifescan, Inc. →