March 25, 2013
Johnson & Johnson Recalls Glucose Meters Due To Equipment Malfunction
Brett Smith for redOrbit.com - Your Universe Online
Johnson & Johnson has announced the voluntary recall of more than 2 million blood glucose meters due to a potentially dangerous malfunction when measuring high glucose levels, according to the company´s LifeScan unit.The recall will affect about 90,000 OneTouch Verio IQ units in the United States that fail to report a warning and shut down for meter readings of 1024 milligrams per deciliter and higher.
“Our patients´ safety is our number one priority,” Dr. Michael Pfeifer, LifeScan´s Chief Medical Officer, said in a statement. “When we learn that a product does not fully meet our expected standards, we will voluntarily notify our customers and patients and take corrective action. We regret the inconvenience these actions may cause.”
“However, we will always err on the side of caution and make a decision that is in the best interest of our patients,” he said.
LifeScan said it has notified the FDA of the voluntary recall, as well as hospitals, healthcare professionals and registered users.
Besides the Verio IQ model, the company is also recalling about 670,000 of its OneTouch Verio Pro glucose meters in Europe and 4,900 of its OneTouch Verio Pro+ models that were sent to the Middle East, Europe and the Asia/Pacific region. Another related model, the OneTouch Ultra, was not affected by the recall.
Despite the potentially dangerous malfunction, there have been no reports of US patient injuries or death due to the defective device, the company said. LifeScan noted one report of “a serious adverse event” for its OneTouch Verio Pro Meter outside the United States. However, it wasn´t clear if the meter played a direct role in causing the event, according to the company.
Johnson & Johnson said it would replace the defective devices free of charge and patients should call 800-717-0276 to make arrangements for a new glucose meter. The company said patients could continue using the Verio IQ model as long as they are aware that the unit might shut down when reading dangerously high glucose levels.
The glucose meter recall is the latest in a series of about three dozen recalls that stretch back to 2009. The most infamous Johnson & Johnson recall over the past three years is probably surrounding the company´s defective hip implants that have been reported to release metal into a patient´s blood stream. Earlier this month, a Los Angeles jury awarded $8.3 million to a retired Montana prison guard due to injuries suffered from the defective ASR XL hip implant.
Besides being potentially hazardous for patients, the spate of defective products and recalls have been a public relations debacle for the company, which stands in sharp contrast to the image it cultivated during the 1980s amidst the famous Tylenol recall.
When seven people died in 1982 after ingesting Tylenol that had been tampered with, Johnson & Johnson pulled millions of bottles off store shelves within a few days. To prevent further tampering, the company introduced sealed packaging that has become an industry standard. The speed, transparency, and pro-activeness with which the company handled the Tylenol disaster has become the model for handling corporate public relations crises.