LifeScan, a unit under Johnson & Johnson, in conjunction with the FDA, has offered warnings about the use of LifeScan’s OneTouch SureStep test strips, as they have been found to falsely identify blood glucose levels in diabetes patients.
Milpitas, Calif.-based LifeScan has voluntarily recalled eight lots of its test strips due to their potential to provide patients with false, low readings of blood glucose levels when in actuality the levels may be higher than 400 mg/dL.
The FDA said these falsely identified low test results could warrant patients to allot an insulin dose that is insufficient, resulting in poor blood glucose control.
Test strips were administered between Aug. 1, 2009, and Jan. 28, 2010, and the company has recalled the following lot numbers:
- # 2969251, 100-ct OneTouch SureStep
- # 2969798, 100-ct OneTouch SureStep
- # 2982369, 100-ct OneTouch SureStep
- # 2983467, 100-ct OneTouch SureStep
- # 2969795, 50-ct OneTouch SureStep
- # 2982566, 50-ct OneTouch SureStep
- # 2969481, 50-ct Medicare/Mail Order
- # 2998193, 50-ct Medicare/Mail Order
LifeScan has recommended that healthcare facilities equipped with these test strips use an alternate form of testing until replacement test strips become available. Physicians should tell their patients who do not have an alternate method for measuring blood glucose levels to contact them if a glucose level above 400 mg/dL is recorded.
Additionally, the company has notified facilities that may be using the SureStep Pro, SureStep Flexx because of their potential to provide inaccurate test results.
Physicians can also urge their patients to call LifeScan at 1-800-574-6139 to order replacement strips. The company said that it will offer the replacement test strips free of charge.