|FreeStyle InsuLinx blood glucose meter--Courtesy of Abbott|
In April, Abbott Laboratories ($ABT) announced it was yanking the FreeStyle InsuLinx blood glucose meters off the U.S. market, and now the FDA has assigned its most-serious Class I label to the effort, warning that the devices' malfunction could lead to serious injury or death.
Abbott recalled the devices over a risk they would give an inaccurate reading at extremely high blood glucose levels. When a patient's reading exceeds 1,024 mg/dL, InsuLinx will display the difference, telling users with blood glucose of 1,066 mg/dL that their levels are 42 mg/dL, according to the FDA.
While blood glucose readings that high are rare, they're also dangerous, so Abbott is advising patients to either replace the meters altogether or update their software on the company's website. In the meantime, Abbott is cautioning users to seek medical attention if their symptoms don't match their meter readings and asking physicians to cease dispensing FreeStyle InsuLinx devices to patients.
The FDA is asking patients and physicians to report any adverse events from the FreeStyle InsuLinx through its online MedWatch platform.
The problem mirrors that of rival Johnson & Johnson ($JNJ) with its OneTouch VerioIQ meters, distributed through LifeScan. Those devices were prone to shutting down when patients' blood glucose crossed 1,024 mg/dL. The FDA assigned a Class I tag to that recall in April.
- read the FDA's note