A recall — being tantamount to admitting failure — is never a decision that a healthcare company wants to make, especially as lawsuits can stream in after and sales are likely to collapse. But Johnson & Johnson (NYSE:JNJ), the world’s largest manufacturer of health-care products, was forced to recall 1.9 million glucose meters.
While Bloomberg noted that the recall came in the “wake of a death of a patient in Europe following an inaccurate blood-sugar reading,” Johnson & Johnson spokesman David Detmers stated that the company has not yet been able to determine whether the faulty reading led to the death.
Johnson & Johnson has determined that, due to a software malfunction, the devices shut off or provide faulting data when a user has an extremely high blood sugar level of 1,024 milligrams per deciliter and higher. “The likelihood of experiencing an extremely high blood glucose level of 1024 mg/dL or higher is remote, noted the company’s press release. “However, when such a blood glucose level occurs, it is a serious health risk requiring immediate medical attention.”
Johnson & Johnson’s recall affected three models of the meter — including the OneTouch VerioIQ, which sold 90,000 units in the United States — Detmers told Bloomberg in a phone interview on Sunday.
An internal company test first illuminated the malfunction and prompted an investigation late last year, said Detmers. But it took time to confirm and evaluate the scope of the software malfunction after the problem was discovered. “After concluding that investigation, we made the decision to recall the three affected products,” he added.
No such problems have been reported in the United States, but because the “products are not performing as intended at these high blood-glucose levels,” a recall was necessary. “We place patient safety first and want to make sure we remove the products and replace them,” the spokesman added.
Johnson & Johnson has been forced to recall numerous products since 2010, including over-the-counter medicines like children’s Tylenol, metal hip implants, and a bone putty used to stop bleeding. The recalls have forced the New-Jersey company to shut down a factory and allow U.S. regulators to oversee some manufacturing.
Now, Johnson & Johnson will have to contend with the loss of sales from its glucose meters. Sales of the devices have been “very modest,” according to spokesman Ernie Knewitz, who declined to give Bloomberg any further details about its profitability. However, the publication noted that the LifeScan unit generated $2.6 billion in 2012 sales of diabetes care products — like glucose meters — as the company reported in a regulatory filing.
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