Abbott recalls 359mn diabetic test strips over false readings

The Food and Drug Administration (FDA) cautions, "This can lead users to try to raise their blood glucose when it is unnecessary, or to fail to treat elevated blood glucose due to a falsely low reading. Both scenarios pose health risks."

Reasons for false results
According to the company, the inaccurate readings may be because the strips are not absorbing enough blood to give the precise glucose readout.

This defect may be due to the age of the strips or them being exposed to and stored in a warm environment for a longer time period.

A statement on the FDA website declared, "The lot numbers under recall may give falsely low blood glucose results. 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."

Brands involved in the recall
The test strips involved in the recall were sold both online and at retail stores and are being used by both consumers and health care professionals.

The brands include Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima.

The defective strips were manufactured between January and September 2010 and were distributed across the United States and Puerto Rico.

Abbott is urging customers who own affected strips to check the lot numbers that appear at the bottom of each box of strips as well as on each foil packet at the company’s website.

Those using defective strips should get them replaced from Abbott Laboratories free of charge.

In addition, customers can call Abbott customer service at 1-800-448-5234 (1-800-709-7010 for Spanish), or visit the FDA's web page, for more information about the recall.

"The lot numbers under recall may give falsely low blood glucose results. 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."--FDA

Some recommendations
Customers are advised to use alternate systems to test sugar levels while waiting for replacements.

However, in case of inaccessibility of strips the patients may use the affected brands in the interim period but count the time taken to register the readings.

If it takes longer than five seconds, the strip is defective and should be discarded.

It is imperative that patients are aware of symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia) and consult their health care provider on experiencing them.

Dr Alberto Gutierrez, director for the office of in vitro diagnostics in FDA's Center for Devices and Radiological Health, stated, "Patients with diabetes should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health.

"FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future.