LifeScan announces global recall of blood glucose meters

LifeScan has issued a worldwide voluntary recall of three of its products used to test and monitor blood glucose in people after finding that it fails to operate correctly at extremely high glucose levels .
The company, part of the Johnson and Johnson brand, said on Monday that nearly 2 million blood glucose meters are being recalled as the meters malfunction at dangerously high blood glucose readings of 56.8 mmol/L and above, which could potentially delay the diagnosis and treatment of severe hyperglycemia or result in incorrect treatment .
The recall affects some 1.2 million of its OneTouch Verio IQ meters worldwide, about 670,000 OneTouch Verio Pro meters in Europe and 4,900 of its hospital and clinic-based OneTouch Verio Pro+ meters in the Middle East, Europe and the Asia/Pacific region.
With the OneTouch Verio IQ Meter, the unit turn offs instead of displaying the message “Extreme High Glucose above 33.3 mmol/L” as intended. If the user’s next test shows a glucose level of 56.8 mmol/L or above, the meter will shut down again.
At the same extremely high blood glucose levels, the OneTouch Verio Pro Meter displays and stores in memory an incorrect test result that is 56.8 mmol/L below the measured result, while the OneTouch Verio Pro+ model displays the correct message, but stores an incorrect test result that is 56.8 mmol/L below the measured result in the results log.
LifeScan said it has notified the US Food and Drug Administration (FDA) and other health regulators around the globe of the voluntary recall, as well as healthcare professionals, registered users, pharmacies and suppliers of the three diabetes monitoring products.
In a statement, the company confirmed that patients may continue to use the Verio IQ Meter only until replacements arrive as long as they are aware that an unexpected shutdown of their device could be a sign of dangerously high glucose levels .
It added that there has only been one report of a serious adverse event relating to the OneTouch Verio Pro Meter, although it has not been determined whether the faulty device was a casual factor.