December 23, 2010

Abbott Diabetes Care Announces Recall


Update: Abbott Diabetes Care Announces Recall of Certain Lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips in the United States and Puerto Rico

  • No other Abbott Diabetes Care products are affected
  • For information on affected lots, please call (800) 448-5234 (English) or (800) 709-7010 (Spanish).

 

Abbott Diabetes Care today announced that it has initiated a recall of 359 lots (approximately 359 million strips) of Precision Xtra , Precision Xceed Pro , MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips in the United States and Puerto Rico.

The test strips are used with Abbott's Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium and OptiumEZ blood glucose monitoring systems. ReliOn Ultima test strips are used with the ReliOn Ultima blood glucose monitoring system. The blood glucose monitors are not being recalled and customers can continue to use the blood glucose monitors.

The affected test strips may give falsely low blood glucose results, which can lead users to try to raise their blood glucose when it is unnecessary and to fail to treat elevated blood glucose due to a falsely low reading. The problem appears to be related to longer than expected blood fill times. This may be dependent on the age of the strips and if the strips have been stored in (or exposed to) higher temperatures (above 72ºF and not to exceed 86ºF) for an extended period of time.

Customers who have test strips from these affected lots should discontinue use of the product. Abbott Diabetes Care will replace affected test strips at no charge. Abbott Diabetes Care initiated this recall following a routine internal quality review that indicated certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima blood glucose test strips may experience longer than normal blood fill times which may cause falsely low blood glucose readings.

Customers are advised to contact their health care provider to determine testing options if they do not have any unaffected test strips to use.

However, if consumers must use affected test strips while in the process of obtaining new strips, they should:

  1. Check the amount of time it takes for their blood glucose meter to start the "countdown" after they first apply blood to the test strip. They should start timing immediately after blood first makes contact with the test strip. If the meter takes longer than five seconds to start the countdown, that test strip is affected and the result should not be used. Users should check the time for each test strip they use because all of the strips in a package may not be affected to the same degree. If any reading appears lower than they would expect or does not seem to correlate with the way they are feeling, the user should contact their health care provider immediately.
  2. If they do not immediately have access to unaffected strips and are unable to test their blood sugar, users need to be aware of symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia).
    • Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting, and abdominal pain. If a user is experiencing any of these symptoms or is not feeling well, they should contact their 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 a user is unable to obtain unaffected strips, they should contact their health care provider for advice on how to treat these symptoms before they occur.

 

The recommendation is that hospitals and user facilities stop using the recalled test strips and follow the steps below:

  1. Use test strips from unaffected lots.
  2. If the health care facility does not have any test strips from unaffected lots but has an alternative point-of-care blood glucose testing system, begin using the alternative system until new, unaffected test strips can be obtained.
  3. If the health care facility does not have any test strips from unaffected lots or immediate access to an alternative point-of-care blood glucose testing system, health care providers should take the following steps:
    • Verify any critical glucose test results (e.g., test results that may be used to adjust insulin therapy in vulnerable patient populations) generated on the Precision Xceed Pro Blood Glucose Monitoring System using a central laboratory blood glucose method. Clinical judgment should be applied when deciding whether to act on results prior to verification.
    • Verify any Precision Xceed Pro Blood Glucose Monitoring System results that do not match a patient's symptoms, or seem unexpected for the patient's clinical status, using a central laboratory blood glucose method.
    • Monitor the amount of time it takes for the Precision Xceed Pro Blood Glucose Meter to start the "countdown" after blood is first applied to the test strip. If the amount of time exceeds five (5) seconds, discard that test strip immediately because the blood glucose result may be erroneously low. In addition, if this occurs:
      • Note the specific lot number of that test strip;
      • Notify Abbott Diabetes Care to report the observed problem with that lot by calling 1-877-529-7185;
      • Make sure to check fill time on each individual strip during use and do not assume if one strip in a package/lot appears to be unaffected, that all strips in that package/lot are unaffected.

 

Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima customers can get information by calling Abbott Diabetes Care customer service at 1-800-448-5234 (English) and 1-800-709-7010 (Español).

The website and customer service phone numbers listed above will also provide customers with information about returning affected test strips.

Unaffected Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strip lots may be used by customers to test their blood glucose as directed by their health care providers.

Abbott Diabetes Care has reported this situation to the U.S. Food and Drug Administration and is working to make the necessary corrective actions to prevent this situation from recurring.

URGENT PRODUCT RECALL - DISCONTINUE USE AND RETURN AFFECTED PRODUCT LOTS

For information on affected lots, please call (800) 448-5234 (English) or (800) 709-7010 (Spanish).

June 24, 2010

Abbott Receives FDA Clearance for New, Easier-to-Use FreeStyle Test Strips


Abbott Receives FDA Clearance for New, Easier-to-Use FreeStyle Test Strips

  • New FreeStyle test strips do not use the GDH-PQQ enzyme.
  • New FreeStyle test strips are compatible with all FreeStyle blood glucose monitors and offer a better blood glucose testing experience.

 

Following the recent clearance of its FreeStyle blood glucose test strips, Abbott today announced that it has also received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new FreeStyle blood glucose test strips. The new FreeStyle test strips minimize interference during blood glucose testing and are designed to offer a better testing experience.

In a similar fashion to the FreeStyle blood glucose test strips, the new FreeStyle test strips do not use the GDH-PQQ1 enzyme, which can be affected by common non-glucose sugars. The new FreeStyle test strips use a GDH-FAD2 enzyme which is unaffected by common non-glucose sugars, such as maltose or galactose, and minimizes the potential for other interference.3

"Abbott's new FreeStyle test strips offer innovative technology that delivers on what patients and health care professionals demand in diabetes care," said Heather L. Mason, senior vice president, Abbott Diabetes Care. "The innovative technology minimizes interference and is designed to make the new FreeStyle test strips easier to use."

The new FreeStyle test strips are compatible with all FreeStyle blood glucose monitoring systems, eliminating the need to switch meters. The FreeStyle strips feature a new, easier-to-use tapered design with ZipWik* tabs that offers a better blood glucose testing experience. The new strips are designed to ensure faster blood application and to reduce the number of error messages and wasted test strips.

The first shipments of new FreeStyle test strips will ship to U.S. customers in August. Retailers and consumers can expect widespread availability by the end of October 2010. With FDA clearance of the new FreeStyle test strips, new FreeStyle and FreeStyle Lite test strips will now be available in the US and 15 European countries. Over the coming months, the new FreeStyle and FreeStyle Lite test strips will be available to customers in Australia, Israel and Norway.

Related Resources and Links

 

About Abbott Diabetes Care
Abbott Diabetes Care, based in Alameda, California, is a leader in developing, manufacturing and marketing glucose monitoring systems designed to help people better manage their diabetes. Additional information about Abbott Diabetes Care may be found at www.abbottdiabetescare.com.

 

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 83,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's web site at www.abbott.com.

April 8, 2010

Important Note To Customers: FreeStyle Navigator Continuous Glucose Monitoring System


Abbott Diabetes Care is committed to quality in its products and to providing the best level of customer service. We take seriously our role in helping people with diabetes monitor their blood glucose. That's why we designed the FreeStyle Navigator Continuous Glucose Monitoring System, which established a new level of accuracy in continuous glucose monitoring.

We are currently experiencing a supply interruption with the FreeStyle Navigator Continuous Glucose Monitoring System. This interruption means we have been unable to follow our normal complaint resolution process, which is to provide patients with replacement receivers and transmitters. We also have been unable to provide FreeStyle Navigator Continuous Glucose Monitoring System kits to new customers.

At present, we cannot estimate when the supply of the FreeStyle Navigator Continuous Glucose Monitoring System will resume.

We recognize that customers are frustrated with the delay and we regret the inconvenience. We are proactively contacting customers who need replacement receivers and transmitters to advise them of the actions we are taking to meet their needs.

If you are a customer who needs a replacement FreeStyle Navigator receiver or transmitter, we are offering a range of options to meet your needs. Please contact customer service at 1-800-221-7700 and we will assist you.

It is important to note that this does not affect working FreeStyle Navigator receivers or transmitters currently in use by patients. Furthermore, no other Abbott Diabetes Care or FreeStyle products are affected by this situation.

We are committed to doing everything we can to resolve this situation quickly.

Thank you for making Abbott Diabetes Care your partner of choice.



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