Patients who use blood glucose meters manufactured by Abbott Laboratories have been warned by the company to take caution and examine their display screens carefully if they have dropped the meters on a hard surface.
According to a statement from Abbott on Aug. 31, if any Precision Xtra, Optium, ReliOn Ultima, Rite Aid, or Kroger glucose monitors manufactured after Jan. 31, 2007, have been dropped on a hard surface, “part or all of the display screen may not work properly or may appear blank, which could result in an inability to view blood glucose test results.”
Abbott warns that the inability to view test results may cause serious risk for hypoglycemia or hyperglycemia. Glucose test strips used with the meters have not been affected by the recall, and no injuries have been reported to date.
Abbott has initiated a worldwide medical device correction for these particular meters, which are distributed through retail and mail-order pharmacies, in addition to notifying physicians, pharmacists, distributors, and registered users by letter.
Tama Donaldson, an Abbott spokeswoman, said approximately 330,000 users may be affected.
Ms. Donaldson emphasized that the Food and Drug Administration has not classified the meters for recall, but as a service to consumers the agency posted Abbott's statement on its “Recalls, Market Withdrawals and Safety Alerts” Web page (www.fda.gov/opacom/7alerts.html
Abbott is requesting that any users who have display screens that are not working properly immediately stop using the meters and call the Abbott Diabetes Care line (877-844-4404).
The company also recommends that users immediately perform a meter display check as directed in the user's guide if the meter drops on a hard surface.