Medical Devices

Nova Biomedical Corporation, Specified Lots of Nova Max Glucose Test Strips

Recall Class: Class I

Date Recall Initiated: July 15, 2013

Products:

  • Nova Max Glucose Test Strips
  • Nova Max Plus Glucose Meter Kits that include the recalled test strips

These test strips are sold in retail stores, online directly to consumers, and are used in health care facilities.

The affected lot numbers can be found by visiting Nova Biomedical’s Urgent Medical Device Voluntary Recall Letter disclaimer icon (Scroll down to see "Appendix A: Recalled Lot Numbers/Catalog Numbers-Nova Max Test Strip Recalled Lots" and "Nova Max Plus Meter Kit Recalled Lots.")

These test strips were manufactured from December, 2011 through April, 2013 and distributed from January, 2012 through July 23, 2013.

Other Nova Diabetes Care products are not affected by this recall.

Use: Glucose test strips are used to measure blood sugar levels.

Recalling Firm:
Nova Biomedical Corporation (also known as Nova Diabetes Care or Diabetes Care)
200 Prospect Street
Waltham, Massachusetts 02453

Reason for Recall: Some of these test strips may report false, abnormally high glucose readings. Under certain conditions a false, abnormally high blood glucose level could result in an insulin dosing error that may lead to low blood glucose (hypoglycemia) requiring the user to seek immediate medical attention. Use of these test strips may lead to serious adverse health consequences or death.

Public Contact: Customers may contact Nova Diabetes Care customer service at 1-800-681-7390 to confirm the recalled lot numbers and to replace the affected test strips/ meter kits at no charge.

FDA District: New England District Office

FDA Comments:
On July 31, 2013 Nova Biomedical began sending their Urgent Medical Device Voluntary Recall Letter disclaimer icon by mail to retail stores, wholesale distributors, and health care professionals.

RECOMMENDATIONS FROM NOVA BIOMEDICAL:

For PEOPLE with DIABETES:

  • IMMEDIATELY DISCONTINUE USE of the recalled strips and take the necessary steps to continue to monitor your blood sugar.
  • You may continue testing your blood glucose using any other Nova Max Glucose Test Strip not indicated as part of this recall while waiting for your replacement product to arrive.
  • Check to confirm if you have blood glucose test strips from the affected lots by visiting Nova Biomedical’s Urgent Medical Device Voluntary Recall Letter disclaimer icon or by contacting Nova Diabetes Care customer service at 1-800-681-7390. You will be directed to return the recalled test strips to the company in return for replacement strips at no charge.
  • Use an alternate method to measure your blood glucose (such as a different test system) or purchase at least two weeks’ worth of new, unaffected strips while waiting for replacement strips.
  • Continue to test your blood glucose, even if the only test strips available to you are from the affected lots. Take the following precautions to reduce the chance of a false reading:
    • As stated in the Blood Glucose Monitor Owners Guide and Nova Max Glucose Test Strip Product Insert, perform a quality control solution test to confirm that your vial of Nova Max Glucose Test Strips is working correctly. DO NOT use a test strip vial if the control solution results are not within the expected range.
    • Verify all elevated blood glucose test results that are not consistent with your diabetes history by repeating the test using a new blood glucose test strip from a different vial (if available) or the same vial (if a new vial is unavailable).
    • Contact your health care professional immediately if your reported blood glucose result(s) are not consistent with your diabetes history, how you feel, or if you think your results are not accurate (higher than expected).
  • Pay special attention to signs and symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). Never ignore symptoms or make significant changes to your diabetes management program without speaking to your health care professional.
    • Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.
    • Symptoms of low blood sugar may include trembling, excessive sweating, weakness, hunger, confusion, and headache. Some individuals may have no symptoms at all before they develop unconsciousness or seizures. It is important to treat low blood sugars promptly to avoid loss of consciousness or a seizure. If you are unable to obtain unaffected strips, you should contact your health care professional for advice on how to treat these symptoms before they occur.

For HEALTH CARE PROFESSIONALS:

  • IMMEDIATELY DISCONTINUE distributing the indicated Catalog Numbers found in the appendix to patients and collect all samples that are in your possession. (Read more about this recall in the Urgent Medical Device Voluntary Recall Letter disclaimer icon) and scroll down to see the appendix.
  • Call Nova at 1-800-681-7390 for shipment of replacement products and to expedite their return.

For PHARMACISTS:

  • IMMEDIATELY IDENTIFY all Nova Max Glucose Test Strips and Nova Max Plus Meter Kits from the indicated Catalog Numbers/Lot Numbers in the appendix that you have in inventory and return those for a credit following your normal return procedures. (Read more about this recall in the Urgent Medical Device Voluntary Recall Letter disclaimer icon) and scroll down to see the appendix.

To determine if you have the product being recalled:

  • Call Nova Diabetes Care Customer Service at 1-800-681-7390 to verify the Lot #s for Nova Max Glucose Test Strips and Nova Max Plus Glucose Meter Kits.

For DISTRIBUTORS:

IMMEDIATELY IDENTIFY and HOLD ALL recalled Nova Max Glucose Test Strips and Nova Max Plus Meter Kits from the indicated Catalog Numbers/Lot Numbers you have in your inventory. Communicate this replacement program to your customers who purchased the indicated products from you. Request that they return only the indicated Catalog Numbers/Lot Numbers per your normal return procedures.

Once you have received all products to be returned, call Nova Diabetes Care at 1-800-681-7390 for a returned goods authorization (RGA) and product review instructions. (Read more about this recall in the Urgent Medical Device Voluntary Recall Letter disclaimer icon and scroll down to see the list of recalled catalog numbers/lot numbers.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Page Last Updated: 08/15/2013
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