|Johnson & Johnson is recalling its VerioIQ glucose monitor.--Courtesy of J&J|
Last month, Johnson & Johnson ($JNJ) voluntarily recalled three models of its market-leading LifeScan glucose meters, and now the FDA has slapped a Class I label on the stateside effort, warning that use of the device could lead to serious injury or death.
At issue are the OneTouch VerioIQ, OneTouch VerioPro and OneTouch VerioPro+ glucose meters, which J&J said will shut down when blood sugar rises above 1,024 milligrams per deciliter, a sky-high level requiring immediate medical attention. The malfunction could lead to improper diagnosis or delayed treatment, the company said, and one European patient died after using the VerioPro. Only the VerioIQ was sold in the U.S.
J&J said the malfunction is caused by a software problem, and the company is in the process of shipping out replacement meters to affected customers. In the meantime, J&J is advising them to keep using their devices, but to contact a doctor if the meter unexpectedly shuts off.
The FDA, in assigning the Class I tag to the VerioIQ recall, is asking customers and physicians to report any adverse events through its online MedWatch platform.
About 1.9 million devices around the world are affected by the recall, including 90,000 in the U.S., according to J&J. There have been no reported adverse events in America, the company said, and it is still investigating whether VerioPro's errant reading contributed to the European patient's death.
The company hasn't said how much it expects the recall to cost, but VerioIQ only modestly contributes to LifeScan's nearly $2.6 billion in annual revenue, J&J said.
At the same time, J&J is dealing with a Class I recall in its insulin pump unit, announcing earlier this month that the Animas 2020 device is prone to errant alarms that can put patients at risk for over-infusion if they don't follow the pump's instructions.
- read the FDA's note
Correction: An earlier version of this story misstated which glucose meter was sold in the U.S. We regret the error.