Abbott Diabetes Care Recalls Test Strips Due to False Readings

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Monitoring glucose levels are important for the proper management of diabetes. Unfortunately, a maker of multiple brands of glucose test strips has discovered that several hundred lots of their product have been found to falsely deliver low readouts with could result in inappropriate treatment for diabetic patients.

A low readout may lead patients to fail to treat elevated glucose levels or they may attempt to try to raise a low blood sugar by mistake, both of which pose a health threat warns the FDA.

Abbott Diabetes Care has initiated a voluntary recall of 359 lots (approximately 359 million strips) of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima Blood Glucose Test Strips in the United States and Puerto Rico. The strips fail to absorb sufficient blood to give a true glucose reading, particularly if the products are stored in a warm environment (temperatures higher than 72 degrees F) or for a long period of time.

Abbott is working with the US Food and Drug Administration (FDA) to find the source of the defect, says Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics.

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The strips were manufactured between January and May 2010. They were marketed to both consumers and healthcare professionals. A complete list of product lots that were affected can be found on the website for Abbott Diabetes Care.
Consumers with test strips affected by the recall should discontinue use of the product. Abbott is offering replacement products free of charge. The Abbott Diabetes Care Customer Service Line is 800-448-5234.

Patients should use an alternate system for testing blood glucose until replacement strips arrive. However, should no other system or strip be available, the company warns not to stop testing.

If consumers continue to use one of the affected lots, they should count the amount of time it takes to register a result. Results that take longer than five seconds could indicate a defective glucose strip.

Patients should also monitor for physical symptoms of both hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar) which include:

• Hyperglycemic patients may be excessively thirsty, urinate excessively, and experience blurred vision, weakness, nausea, vomiting, and abdominal pain.
• Hypoglycemic patients may feel trembling, excessive sweating, weakness, hunger, confusion, and headache, though some patients may not experience symptoms before developing unconsciousness or seizures.

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