The US Food and Drug Administration has recalled up to 359 million diabetes test strips that may give falsely low blood glucose results.
The products are available in Cayman and have been removed from sale.
According to a press release from the FDA, the Abbott Diabetes Care strips could give false results that may lead patients to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of false, low reading.
Both scenarios pose risks to a patient’s health.
The Cayman Islands Health Services Authority does not carry these products, but all local pharmacies and distributors have been advised of the recall, said Medical Officer of Health Dr. Kiran Kumar.
Members of the public who have this product should consult the pharmacy where it was purchased or their physicians, he said.
The recalled glucose test strips are used on Abbot’s Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ, and ReliOn Ultima blood glucose monitoring systems.
These strips are used with Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems. The blood glucose monitoring systems are not affected by this recall.
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.
The test strips were manufactured between January and September 2010 and are sold in retail and online settings directly to consumers.
“Patients with diabetes should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health,” said Alberto Gutierrez, director for the Office of In Vitro Diagnostics in FDA’s Centre for Devices and Radiological Health. “FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future.”
Consumers who wish to find out if glucose testing strips in their possession are subject to the recall can also 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, or visit www.precisionoptiuminfo.com to look up test strip lot numbers. Lot numbers of the products can be found on the bottom of the packaging.
Further advice on the recall can be found on the US Food and Drug Administration website at www.fda.gov