J&J recalls nearly 2 million blood glucose meters worldwide
March 28th, 2013 // 4:00 pm @ jmpickett
May 7 – FDA Recall Chief Update – How to Design a Bulletproof Product Recall Strategy
Johnson & Johnson is recalling and replacing nearly 2 million meters used to measure blood glucose levels in diabetics due to a failure to operate properly at extremely high glucose readings, the company’s LifeScan unit said on Monday.
In the United States, about 90,000 OneTouch Verio IQ meters are affected out of some 1.2 million units of that model being recalled worldwide, the company said.
At extremely high glucose readings of 1024 mg/dl and above, the units have failed to provide a warning of dangerously high blood sugar and will shut off, potentially delaying proper treatment, the company said.
LifeScan said it has notified the U.S. Food and Drug Administration and other health regulators of the voluntary recall, as well as registered users and healthcare professionals.
Upcoming Expertbriefings.com Webinars 2013
Check out our latest FDA drug and device news, too
- April 3 – Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance
- April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission
- April 11 – The Quality Manager Gets Fired, the $100,000 Compliance SNAFU, And 21 Tips and Tricks For Your Next Audit
- April 18 – Why You May Want to Move Your Pharma Company to Kansas – 483 and Warning Letter Trends
- April 21 – $500K on Compliance or $300 Million for Consent Decree? – Essential FDA Compliance Tips for Sr Management
- April 30 – FDA Hands Out CAPA 483s Like Candy – Avoid Them With a Closed Loop CAPA SystemÂ
- May 1 – Avoiding Warning Letter Disasters With a Strong Contractor Quality Agreement
In addition to the Verio IQ model, J&J is also recalling about 670,000 of its OneTouch Verio Pro meters in Europe and 4,900 of its hospital-based OneTouch Verio Pro+ meters in the Middle East, Europe and the Asia/Pacific region.
No patient injuries have been reported in the United States related to the malfunction, the company said. LifeScan said there was one report of a serious adverse event outside the United States, but a link to the malfunctioning glucose meter had not been determined.
“We regret the inconvenience these actions may cause. However, we will always err on the side of caution and make a decision that is in the best interest of our patients,” Michael Pfeifer, LifeScan’s chief medical officer, said in a statement.
The company said its OneTouch Ultra model was not affected by the recall.
It said patients could continue to use the Verio IQ model until replacements arrive as long as they are aware that if the unit shuts down it could be indicative of dangerously high glucose levels.
