Diversified healthcare company Abbott Laboratories (ABT: Quote) Monday announced a voluntary recall of FreeStyle InsuLinx Blood Glucose Meters in the U.S., as it is likely to provide an inaccurate reading at ‘extremely high’ blood glucose levels.
Abbott estimates that there are about 50,000 active FreeStyle InsuLinx Meter users in the U.S. The company noted that no other Abbott blood glucose meters are impacted by this issue.
According to the company, at extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. However, blood glucose levels at 1024 mg/dL and above are very rare, but such a situation is a serious health risk and requires immediate medical attention.
When considering a blood glucose value of 1066 mg/dL, the meter will display and store a value of 42 mg/dL (1066 mg/dL – 1024 mg/dL = 42 mg/dL), the company said.
The inaccurate reading, or low result at a blood glucose level above 1024 mg/dL may result in delay in the identification and treatment of severe hyperglycemia or will result in giving an incorrect treatment. This could lead to serious injury or death, Abbott added.
Heather Mason, senior vice president, Diabetes Care, Abbott stated, “Our first priority is to safeguard the health and safety of patients…and we initiated this voluntary recall to ensure our products continue to meet the highest standards of quality and safety.”