The FDA announced today(www.fda.gov) that Abbott Diabetes Care has agreed to recall more than 350 lots of its blood glucose test strips because the products may give falsely low test results. According to the agency, such results may lead patients to try to raise their blood glucose levels unnecessarily, or patients may fail to treat elevated levels because of a falsely low reading. Either scenario poses risks to patients' health, say FDA officials.
The 359 lots of test strips being recalled are sold under the following brand names:
- Precision Xceed Pro,
- Precision Xtra,
- Medisense Optium,
- OptiumEZ and
- ReliOn Ultima.
The affected strips are used with Abbott's Precision Xceed Pro, Precision Xtra, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems. The systems themselves are not included in the recall, which is related to the test strips' inability to absorb adequate blood for monitoring.
The FDA notes that as many as 359 million products distributed in the United States and Puerto Rico may be affected.
The affected strips, which were manufactured between January and September of this year, are sold to individual consumers via retail outlets and online and also are used in hospitals and other health care facilities throughout the country. Consumers may check online(www.abbottdiabetescare.com) to see if their test strips are from one of the recalled lots or call Abbott at (800) 448-5234 (English) or (800) 709-7010 (Spanish) to speak with a customer service representative. Abbott will replace the affected products at no charge.
The FDA recommends that while waiting for the replacement strips to arrive, patients should use an alternate method to measure blood glucose, such as a different testing system, or purchase at least two weeks' worth of new, unaffected strips. Consumers can ask their pharmacists for help ensuring that the strips they plan to purchase are not from affected lots.
Adverse effects associated with using the strips should be reported to the FDA's MedWatch Adverse Event Reporting System(www.fda.gov).