LifeScan Announces Recall, Hospital Warning for Glucose Monitoring Strips

Kate Traynor

BETHESDA, MD 26 February 2010—LifeScan Inc. this week announced a recall of eight lots of OneTouch SureStep test strips that may result in "falsely low" blood glucose readings when the user's blood glucose is greater than 400 mg/dL.

The recalled lots are 2969251, 2969798, 2982369, and 2983467, sold in boxes of 100 each; 2969795 and 2982566, sold in boxes of 50 each; and 2969481 and 2998193, sold in boxes of 50 each and described by the company as "Medicare/Mail Order."

Replacements for the recalled strips can be ordered online or requested by phone at 800-218-3168.

The company also issued a warning to hospitals about SureStepPro test strips producing inaccurately low readings when used with the company's SureStepPro, SureStepFlexx, or OneTouch SureStep Hospital Blood Glucose Monitoring Systems.

According to LifeScan, the hospital monitors are designed to display "high" or "Hi" whenever the blood glucose level exceeds 500 mg/dL. But recently manufactured SureStepPro test strips may instead display a false low reading when blood glucose levels exceed 400 mg/dL.

The example given in the announcement is that an actual blood glucose value of 650 mg/dL may display as 469 mg/dL instead of "High" or "Hi."

The company asked hospitals to consider using an alternate blood glucose measuring system, if one is available, until replacement strips are provided. If no other measurement process is available, hospitals may reset the "Critical High" value on the monitor to 400 mg/dL, by following the instructions in the announcement and then clinically assess patients as a preliminary guide to treatment.

Health care professionals who need additional information about the issue should call LifeScan at 800-218-0221.