Glucose test strips which may give falsely low blood glucose readings are being recalled by Abbott Diabetes Care from US retail outlets, online outlets, and health care facilities in the USA, the FDA (Food and Drug Administration) reported. The recall relates to 359 different glucose test strip lots with the following brand names:
- Medisense Optium
- Precision Xceed Pro
- Precision Xtra
- ReliOn Ultima
The test strips have been distributed in the USA and Puerto Rico. The FDA stresses that other Abbott Diabetes Care products are not affected.
A falsely low blood glucose result - a risk in these recalled strips - may cause the patient to raise his/her blood glucose unnecessarily, or a high blood glucose might read as normal, or even low. In both cases, there is a risk to health.
The defective strips, which were manufactured between January and September 2010, do not absorb enough blood for proper monitoring. They might have been in a warm environment or stored for too long.
The defective strips have been bought by consumers and are also used in health care facilities.
Alberto Gutierrez, Ph.D., director for the Office of In Vitro Diagnostics in FDA's Center for Devices and Radiological Health, said:
- "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."
- Telephone 1-800-488-5234 (English), or 1-800-709-7010 (Spanish) to speak to an Abbott Diabetes Care customer services representative.
- Click here for a list of affected test strip lot numbers.
Written by Christian Nordqvist