Johnson & Johnson Recall: Blood Glucose Meters

by The Rothenberg Law Firm LLP

In March 2013, LifeScan, a division of Johnson & Johnson, announced a voluntary recall and replacement of approximately 90,000 blood glucose meters in the United States and nearly 2 million meters worldwide. According to the Johnson & Johnson website, the particular meter affected in the United States is the OneTouch® Verio® IQ meter. Other LifeScan products in the United States have not been affected by the recent recall.

Outside of the United States, three different brands are being recalled;

1) OneTouch® Verio® IQ;

2) OneTouch® Verio® Pro; and

3) OneTouch® Verio® Pro+.

What is the wrong with the OneTouch® Verio® products?

At extremely high blood glucose levels, specifically 1024 milligrams per deciliter (mg/dL) and above, the OneTouch® Verio® IQ blood glucose meter will not display a warning of the extremely high blood glucose level. Instead, the meter will shut itself off.

Outside the United States, the recalled products will also malfunction at very high blood

glucose level readings by way of “incorrect glucose value display or record storage.”

What is the risk of injury for users?

When a blood glucose level of 1024 mg/dL occurs, an individual is at a serious risk of acute hyperglycemia. If acute hyperglycemia is left untreated, it can lead to ketoacidosis (dangerously high levels of ketones built up in a person’s blood) or Hyperosmolar Hyperglycemic Nonketotic Syndrom (HHNS). Both ketoacidosis and HHNS are serious emergencies that require immediate medical attention.

Because the defective blood glucose meters simply turn off at such high levels of blood glucose, users who are not aware of the malfunction may not be aware of their life-threatening situation and simply believe that their meter shut off for a different reason. Treatment may be delayed or an incorrect diagnosis might be made, possibly resulting in serious health problems or even death.

To prevent the development of serious complications from hyperglycemia, users of blood glucose meters should always be aware of early symptoms of possible hyperglycemia - even if their meter reading is normal.

Such symptoms include:

  • Polydipsia (frequent or excessive thirst)
  • Headaches
  • Polyphagia (frequent, pronounced hunger)
  • Difficulty concentrating
  • Blurred vision
  • Polyuria (frequent urination)
  • Fatigue (weak, tired feeling)
  • Weight loss
  • Blood sugar more than 180 mg/dL

If hyperglycemia in diabetics is prolonged, it may result in:

  • Cardiac Arrhythmia
  • Vaginal and skin infections
  • Slow-healing cuts and sores
  • Decreased vision
  • Nerve damage causing painful, cold or insensitive feet, loss of hair on the lower extremities, and/or erectile dysfunction
  • Stomach and intestinal problems such as chronic constipation or diarrhea
  • Damage to your eyes, blood vessels, or kidneys               

What should LifeScan OneTouch® Verio® IQ users do?

In the United States, users can immediately arrange to receive a replacement blood glucose meter free of charge simply by calling LifeScan Customer Service at (800) 717-0276, Monday through Sunday, between 8:00 a.m. and 10:00 p.m. Eastern Standard Time. Patients who are aware of the recall and the specific malfunction of the device may continue to use their existing meters while they wait for a replacement. However, LifeScan advises that if the original blood glucose meter suddenly shuts off during testing, you should contact a medical professional as soon as possible because this could signify life-threatening extreme hyperglycemia. Users can learn more about the recall on OneTouch's website.

Johnson & Johnson issued a statement ensuring consumers that the health and safety of their customers and patients is their number one priority. The company has reported the malfunction and recall to all registered users of the blood glucose meter, the Food and Drug Administration, and to healthcare providers, distributors, and pharmacies where this device is sold. Fortunately, this malfunction was discovered before any injuries or adverse events were reported, and hopefully the recall will prevent any future injury. In the event that you experience an injury from a faulty device, call a medical products attorney today.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© The Rothenberg Law Firm LLP | Attorney Advertising

Written by:

The Rothenberg Law Firm LLP

The Rothenberg Law Firm LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.