Abbott recalls blood glucose test strips, after false results

Abbott Diabetes Care has recalled 359 lots of blood glucose test strips after it was found that the affected test strips may give false low blood glucose results.

The estimated 359 million test strips recalled were distributed in both the U.S. and Puerto Rico and include the Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima products.

The strips are used in conjunction with Abbott’s Precision Xtra, Precision Xceed Pro, MediSenseOptium, Optium and OptiumEZ blood glucose monitoring systems; however, Alameda, Calif.-based Abbott said that these monitoring systems are not being recalled.

According to Abbott, due to false results the test strips included in the recall could lead users to try and raise blood glucose levels when it is unnecessary and to fail to treat elevated blood glucose due to false low readings.

The company has advised patients who are using the affected lots to discontinue use of the product. The recalled lots can be viewed here.

For healthcare facilities that do not have access to unaffected lots of the test strips or to alternative point-of-care blood glucose testing systems, Abbott recommends the following steps:

• Verify critical glucose test results generated by the Precision Xceed Pro blood glucose monitoring systems via a central laboratory blood glucose method. This step should be taken particularly when test results are used to adjust insulin therapy in vulnerable patients;
• Verify any Precision Xceed Pro system results that do not match patient’s symptoms or those which seem unexpected for the patient’s clinical status by using a central laboratory blood glucose method; and
• Monitor the amount of time it takes for the Precision Xceed blood glucose meter to start the “countdown” after blood is first applied to the test strip. If that time exceeds five seconds, Abbott recommends discarding the test strip to prevent false low blood glucose results.