🔍 RecallPedia

LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.

Class I - Dangerous
🏥 Medical Devices Recalled: February 25, 2013 Lifescan Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    2AA2G01, Exp. Date: 7-31-2014; 2AA2G02, Exp. Date: 7-31-2014; 2AA2G03, Exp. Date: 8-31-2014; 3AA2G04, Exp. Date: 12-31-2014; 3AA2G05, Exp. Date: 12-31-2014
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Lifescan Inc
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.

Product Codes/Lot Numbers:

2AA2G01, Exp. Date: 7-31-2014; 2AA2G02, Exp. Date: 7-31-2014; 2AA2G03, Exp. Date: 8-31-2014; 3AA2G04, Exp. Date: 12-31-2014; 3AA2G05, Exp. Date: 12-31-2014

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1129-2013

Related Recalls

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.

Lifescan

Class I - Dangerous

The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE.

Mar 11, 2013 Diagnostic Equipment Nationwide View Details →