Health products giant Johnson & Johnson on Monday issued yet another product recall, this one for OneTouch VerioIQ blood glucose meters sold in the U.S. and other countries.
They're being recalled because when a diabetic's blood sugar level is dangerously high, they do not provide a warning and instead turn off, or they display an inaccurate reading.
The meters are made by J&J's LifeScan unit, which will issue a free replacement meter to all patients.
The company said Monday that the meters being recalled in the U.S. 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, 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 stays 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.
Patients can continue using the meter until they receive a new one, the company said.
"Our patients' safety is our number one priority," Dr. Michael Pfeifer, LifeScan's Chief Medical Officer, said in a statement.
J&J said notifications were being sent to an estimated 90,000 active OneTouch VerioIQ Meter users in the U.S., as well as doctors, nurses, pharmacies and distributors. The company is working on an update to the meter to address the problem, but can't say when it will resume shipments of the meters.
Outside the U.S., the company is recalling the OneTouch VerioIQ, OneTouch VerioPro and OneTouch VerioPro+ Brands. The three types are being recalled because, at extremely high glucose levels, they display an incorrect glucose level or don't store the correct gloucose level in their memory.
To date, no patient injuries related to the defects have been reported worldwide for any of the recalled meters.
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.
Follow Linda A. Johnson on Twitter at http://twitter.com/LindaJ_onPharma