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The Food and Drug Administration has recalled millions of glucose test strips because they may be giving low blood glucose results due to their inability to absorb enough blood.
The agency has recommended that consumers and health care professionals immediately discontinue using the affected test strips and switch to an unaffected product.
As many as 359 million strips, which are sold directly to consumers in online or retail stores, and which are used in health care facilities, may be affected by the recall, according to the FDA. The test strips were manufactured between January and May 2010 and have been distributed in the United States and Puerto Rico.
The test strips were manufactured by Abbott and marketed under the following brand names: Precision Xceed Pro; Precision Xtra; Medisense Optium; Optium; OptiumEZ; and ReliOn Ultima. The strips are used with Abbott’s blood glucose monitoring systems, which have the same brand names but are not affected by this recall, according to the FDA.
"Patients with diabetes should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health," Alberto Gutierrez, Ph.D., director for the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA Center for Devices and Radiological Health, said in a statement. "FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future."
For more information on the recalled products, call Abbott Diabetes Care customer service at 1-800-448-5234 (English) or 1-800-709-7010 (Spanish), or visit precisionoptiuminfo.com to look up test strip lot numbers.
The Food and Drug Administration has recalled millions of glucose test strips because they may be giving low blood glucose results due to their inability to absorb enough blood.
The agency has recommended that consumers and health care professionals immediately discontinue using the affected test strips and switch to an unaffected product.
As many as 359 million strips, which are sold directly to consumers in online or retail stores, and which are used in health care facilities, may be affected by the recall, according to the FDA. The test strips were manufactured between January and May 2010 and have been distributed in the United States and Puerto Rico.
The test strips were manufactured by Abbott and marketed under the following brand names: Precision Xceed Pro; Precision Xtra; Medisense Optium; Optium; OptiumEZ; and ReliOn Ultima. The strips are used with Abbott’s blood glucose monitoring systems, which have the same brand names but are not affected by this recall, according to the FDA.
"Patients with diabetes should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health," Alberto Gutierrez, Ph.D., director for the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA Center for Devices and Radiological Health, said in a statement. "FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future."
For more information on the recalled products, call Abbott Diabetes Care customer service at 1-800-448-5234 (English) or 1-800-709-7010 (Spanish), or visit precisionoptiuminfo.com to look up test strip lot numbers.
The Food and Drug Administration has recalled millions of glucose test strips because they may be giving low blood glucose results due to their inability to absorb enough blood.
The agency has recommended that consumers and health care professionals immediately discontinue using the affected test strips and switch to an unaffected product.
As many as 359 million strips, which are sold directly to consumers in online or retail stores, and which are used in health care facilities, may be affected by the recall, according to the FDA. The test strips were manufactured between January and May 2010 and have been distributed in the United States and Puerto Rico.
The test strips were manufactured by Abbott and marketed under the following brand names: Precision Xceed Pro; Precision Xtra; Medisense Optium; Optium; OptiumEZ; and ReliOn Ultima. The strips are used with Abbott’s blood glucose monitoring systems, which have the same brand names but are not affected by this recall, according to the FDA.
"Patients with diabetes should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health," Alberto Gutierrez, Ph.D., director for the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA Center for Devices and Radiological Health, said in a statement. "FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future."
For more information on the recalled products, call Abbott Diabetes Care customer service at 1-800-448-5234 (English) or 1-800-709-7010 (Spanish), or visit precisionoptiuminfo.com to look up test strip lot numbers.
FROM THE FOOD AND DRUG ADMINISTRATION