Tuesday, March 26, 2013

Total Recall contd. - Johnson & Johnson recalls thousands of blood glucose meters

By Bloomberg News
on March 26, 2013 at 11:16 AM, updated March 26, 2013 at 11:19 AM

Johnson & Johnson, the world’s biggest maker of health-care products, said it was recalling almost 1.9 million glucose meters in the wake of a death of a patient in Europe following an inaccurate blood-sugar reading.

The company’s LifeScan unit is recalling the blood glucose meters, including 90,000 that were sold in the U.S., because they shut off or provide inaccurate readings at extremely high blood-sugar levels. The recall affects three models, including one sold in the U.S. called OneTouch VerioIQ, said David Detmers, a company spokesman.

J&J started to investigate the issue late last year when the problem was noticed by internal company testing, he said. Soon after that, a report was received of a European patient who died following an inaccurate, low reading on the OneTouch VerioPro, one of the now-recalled meters.

The New Brunswick-based J&J hasn’t been able to determine whether the faulty reading led to the death, Detmers said. No adverse events have been reported in the U.S.

“The products are not performing as intended at these high blood-glucose levels,” Detmers said yesterday in a phone interview. “We place patient safety first and want to make sure we remove the products and replace them.”

J&J has recalled a variety of products since 2010 including over-the-counter medicines such as children’s Tylenol, metal hip implants and a bone putty used to stop bleeding. The medicine recalls forced J&J to close a factory and sign a consent decree with U.S. regulators to oversee some manufacturing.

The company also faces more than 1,800 lawsuits from women who blame internal injuries on vaginal mesh implants and 10,000 lawsuits from patients who say they got faulty hip replacements.

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