FDA Recalls Abbott Glucose Test Strips for “Falsely Low” Results


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;
* 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 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 pose serious health risks.

The test strips are unable to absorb enough blood for monitoring. Strips exposed to warm weather or prolonged storage may be more likely to provide a false result.

To determine if you have product being recalled:

* Call Abbott Diabetes Care customer service at 1-800-448-5234 (English) and 1-800-709-7010 (Spanish) to speak with a customer service representative.

* Visit www.precisionoptiuminfo.com to look up test strip lot numbers.



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