Urgent: Abbott Notifies Users of Precision Xtra(tm), Optium(tm),
ReliOn(r) Ultima, Rite Aid(r) and Kroger(r) Blood Glucose Meters to
Check Display Screens
Contact:
Tama Antonia Donaldson
(510) 749-5449
FOR IMMEDIATE RELEASE -- Alameda, CA -- August 31, 2007 -- Abbott is
initiating a worldwide medical device correction for users of its
Precision Xtra(tm), Optium(tm), ReliOn(r) Ultima, Rite Aid(r) and
Kroger(r) blood glucose meters manufactured after January 31, 2007. If
the meter is 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. The inability to
generate blood glucose results could result in significant risk for
hypoglycemia or hyperglycemia.
Users of these meters who note that the display screen is not working
properly should immediately stop using their meter as referenced in the
User Guide and call Abbott Diabetes Care customer care for assistance at
1-877-844-4404. Through internal testing, Abbott Diabetes Care has found
that when recently produced meters are dropped onto a hard surface, part
of the display can be jarred or disconnected, thereby making it
difficult to read the lot number or date information, or causing the
screen to appear blank. No injuries have been reported to date.
Patients should keep their glucose meters in the wallet provided to
offer additional protection for the meter. If the meter is dropped on a
hard surface, patients should immediately perform a meter display check.
Instructions on how to do this are detailed in the meter's Users Guide.
If no problems are encountered during the automatic display check, the
meter is ready for use. Customers may call Abbott Diabetes Care customer
care at 1-877-844-4404 to determine the date their meter was
manufactured. Customers may also call customer care if they have
questions or need a replacement meter.
Precision Xtra(tm), Optium, ReliOn(r) Ultima, Rite Aid(r) and Kroger(r)
blood glucose meters have been distributed via retail and mail order
pharmacies, physician offices and distributors. Abbott is notifying
physicians, pharmacists, distributors and registered users by letter.
Blood glucose test strips used with these meters are not affected by
this notification.
More information about this notification is available on the company's
website, www.abbottdiabetescare.com
.
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