abbottglucose2The United States Food and Drug Administration now is assigning its most serious Class I label to the agency’s April recall of Abbott Laboratories’ FreeStyle InsuLinx blood glucose meters because malfunction of the device could cause serious injury and even death.

The FreeStyle InsuLinx devices were initially taken off of shelves because they were discovered to give inaccurate readings to patients whose blood glucose levels rose above 1,024 mg/dL.  According to the FDA, a patient whose glucose level was actually at 1,066 mg/dL could be led to believe it was registering at a healthier level of 42 mg/dL because the device was erroneously reporting the difference in the patient’s actual glucose level and the index level.

Physicians are urged to stop dispensing these devices, and patients using the devices are encouraged to replace their devices or update their software by visiting Abbott Laboratories’ website.  Abbott also suggests that patients using the devices immediately seek medical attention if the severity of their symptoms does not coincide with meter readings.

In addition, the FDA asks that clinicians report any adverse events involving this device through the agency’s MedWatch program.  To access the FDA’s note regarding this recall, click here.