Recalls Update - Thursday, May 2, 2013 17:36 - 0 Comments

J&J Recalls 1.9 Million Blood Glucose Meters

Johnson & Johnson’s LifeScan Inc. unit has recalled nearly 2 million blood glucose meters across the globe after discovering that the meters malfunction when they register extremely high readings. According to the company, three brands of its blood glucose meters shut off when they encounter blood glucose levels of 1024 milligrams per deciliter and higher, rather than display a warning to users that they should seek immediate medical attention. The meters should display the warning for glucose readings of more than 600 mg/dL. Without the warning, patients may not receive the treatment necessary for extreme hyperglycemia, which could result in a serious health risk or fatality, LifeScan said.

While LifeScan is only recalling approximately 90,000 OneTouch Verio IQ meters in the U.S., it’s calling back nearly 1.9 million meters under the OneTouch Verio IQ, OneTouch Verio Pro and OneTouch Verio Pro+ brands in other markets worldwide for the similar faulty reading issues. So far, there have been no patient injury reports within the U.S. and one serious adverse event report outside the country.

LifeScan noted that patients could continue to use the faulty blood glucose meters while awaiting their replacements, but said they should contact a physician if their meter unexpectedly shuts off during testing. It advised health care professionals to stop distributing the meters. “The likelihood of experiencing an extremely high blood glucose level of 1024 mg/dL or higher is remote; however, when such a blood glucose level occurs, it is a serious health risk requiring immediate medical attention,” the company said in a statement.

LifeScan had issued another recall in March of this year for five faulty lots of its OneTouch Ultra Control Solution, which is used to verify meters and test strips work together correctly. According to the company, the solution lots at issue may say the blood glucose meters are malfunctioning when they work properly, which could prompt users to delay blood sugar testing until the issue is resolved.