Abbott Laboratories has recalled as many as 359 glucose testing strips marked under the names Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ, and ReliOn Ultima, because they may reveal falsely low glucose results.
According to Abbott Laboratories, the issue with the potentially defective strips relates to a defect that inhibits sufficient absorption of blood into the test strip. Strips exposed to various elements such as warm weather may be more likely to provide a false result. This can lead patients to raise their blood glucose when it is unnecessary.
The test strips, which were manufactured between January and May 2010, are sold both in retail and online settings directly to consumers, but are also used in health care facilities.
FDA NEWS RELEASE
For Immediate Release: Dec. 22, 2010
Media Inquiries: Erica Jefferson, 301-796-4988, email@example.com
Consumer Inquiries: 888-INFO-FDA
FDA announces recall of Abbott glucose test strips
Strips sold in retail stores, online and used in health care facilities
The U.S. Food and Drug Administration today announced the agency is working with Abbott Diabetes Care to recall 359 different lots of glucose test strips marketed under the following brand names:
- Precision Xceed Pro;
- Precision Xtra;
- Medisense Optium;
- OptiumEZ; and
- ReliOn Ultima
These strips are used with Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems. As many as 359 million strips may be affected by the recall. The blood glucose monitoring systems are not affected by this recall.
The recall pertains to certain lots of these test strips distributed in the United States and Puerto Rico. Other Abbott Diabetes Care products are not affected by the recall.
The test strips being recalled may give falsely low blood glucose results. False results may lead patients to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading. Both scenarios pose risks to a patient’s health.
The recall is related to the test strips’ inability to absorb enough blood for monitoring. Strips exposed to warm weather or prolonged storage may be more likely to provide a false result.
The test strips were manufactured between January and September 2010 and are sold both in retail and online settings directly to consumers, but are also used in health care facilities.
The FDA has provided recommendations for consumers and health care professionals below that explain how to determine whether a particular lot is affected, how to order free replacement strips and how to use recalled strips to reduce the likelihood a false result.
“Patients with diabetes should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health,” said Alberto Gutierrez, Ph.D., director for the Office of In Vitro Diagnostics in FDA’s Center for Devices and Radiological Health. “FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future.”