21010 - LifeScan One Touch Verio IQ Blood Glucose Meter

 

Product Description: LifeScan One Touch Verio IQ Blood Glucose Meter

Manufacturer:  LifeScan, Inc.      Milpitas, CA
 
Date Recall Posted:  3/25/2013
 
 
UPC:
UPC
Description
Key
00000003-53885-00770-2
ONE TOUCH VERIO IQ METER
64
             

Summary of Recall:  LifeScan, Inc. announced in cooperation with the FDA it is issuing a voluntarily recall and replacement of all One Touch Verio IQ Blood Glucose Meters in the United States.

Hazard: LifeScan is recalling and replacing all OneTouch® Verio®IQ Meters because at extremely high blood glucose levels of 1024 mg/dL and above, the meter will not provide a warning that the blood glucose is extremely high and will shut off, thereby potentially leading to incorrect treatment and delaying proper treatment.
The likelihood of experiencing an extremely high blood glucose level of 1024 mg/dL or higher is remote; however, when such a blood glucose level occurs, it is a serious health risk requiring immediate medical attention. Because these products do not provide an appropriate warning at glucose levels of 1024 mg/dL or higher, diagnosis and treatment of extreme hyperglycemia may be delayed or incorrect treatment may be given resulting in potentially serious health risk or fatality.
 
 

What You Should Do:

In Order To Receive Replacement Meters At No Charge, Please Follow The Steps Below:

Please call LifeScan Customer Service at 1-800-717-0276 to verify your OneTouch® Verio®IQ Meter Serial Number and confirm your mailing address so that we may ship you a replacement meter. You can continue to test with your current OneTouch® Verio®IQ Meter while you wait for your replacement meter to arrive. However, If your OneTouch® Verio®IQ Meter unexpectedly turns off and enters set-up mode after turning it back on, your blood glucose may be extremely high, and you should call your health care professional. Never ignore symptoms or make significant changes to your diabetes management program without speaking to your health care professional. Please print and keep this notice with your Owner’s Booklet.
 
Consumer Contact Information: Consumers with questions regarding this recall should contact LifeScan Customer Service for further direction at 1-800-717-0291.
 
Consumers with questions or concerns about their health should contact their Physician.