Johnson & Johnson is recalling all its OneTouch VerioIQ blood glucose meters in the U.S. because they do not provide a warning when a diabetic's blood sugar level is dangerously high. Instead, at a certain sugar level, the meters turn off.
The meters are made by J&J's LifeScan unit, which will issue a free replacement meter to all patients.
The company says the meters shut down when a patient's blood sugar hits 1,024 milligrams per deciliter. That's an extremely high level requiring immediate medical attention.
It's extremely unlikely that a diabetic's blood sugar level would get that high. However, if a patient experienced such extreme high blood sugar and did not get prompt treatment or got an incorrect treatment based on a false meter reading, that could result in a serious health risk or death, according to J&J.
People with diabetes are encouraged to keep their peak blood sugar level, shortly after a meal, at or below 160 milligrams per deciliter.
When blood sugar gets even a little above that level, over time the excess sugar can damage blood vessels, the heart, kidneys, eyes and other organs, eventually resulting in severe complications such as blindness, kidney failure, leg amputations and premature death. Extremely high, sudden spikes can cause death if not treated aggressively.
Johnson & Johnson, based in New Brunswick, N.J., said patients with one of the meters should contact LifeScan's customer service at 800-717-0276 to arrange for a replacement meter or ask questions. Representatives are available from 8 a.m. to 10 p.m. EDT Monday through Sunday.
The recall is J&J's latest in a string of about three dozen since 2009 by Johnson & Johnson, the world's biggest provider of health care products.
Most have involved nonprescription medicines such as adult and children's Tylenol and Motrin, but other recalls were for faulty hip replacements and prescription drugs for conditions such as epilepsy or for contact lenses. Reasons have included wrong levels of active ingredients in medicines, glass or metal shards in liquid medicines and nauseating packaging smells.
The company is operating under increased scrutiny from the U.S. Food and Drug Administration, while it completely rebuilds one nonprescription medicine factory from the ground up and upgrades other factories. The recalls and lost product sales have cost J&J well over $1 billion.