Update: Abbott Diabetes Care Announces Recall of Certain Lots of Precision Xtra®,
Precision Xceed Pro®,
MediSense® Optium™,
Optium™, OptiumEZ and ReliOn® Ultima
Blood Glucose Test Strips in the United States and Puerto Rico
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No other Abbott Diabetes Care products are affected
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More information is available at: www.precisionoptiuminfo.com
ALAMEDA, Calif. Dec. 23, 2010 — Abbott Diabetes Care today announced that it has
initiated a recall of 359 lots (approximately 359 million strips) of Precision
Xtra®,
Precision Xceed Pro®,
MediSense® Optium™, Optium™, OptiumEZ and ReliOn® Ultima Blood Glucose Test
Strips in the United States and Puerto Rico.
The test strips are used with Abbott's Precision Xtra, Precision Xceed Pro,
MediSense Optium, Optium and OptiumEZ blood glucose monitoring systems. ReliOn
Ultima test strips are used with the ReliOn Ultima blood glucose monitoring
system. The blood glucose monitors are not being recalled and customers can
continue to use the blood glucose monitors.
The affected test strips may give falsely low blood glucose results, which can
lead users to try to raise their blood glucose when it is unnecessary and to
fail to treat elevated blood glucose due to a falsely low reading. The problem
appears to be related to longer than expected blood fill times. This may be
dependent on the age of the strips and if the strips have been stored in (or
exposed to) higher temperatures (above 72°F and not to exceed 86°F) for an
extended period of time.
Customers who have test strips from these affected lots should discontinue use
of the product. Abbott Diabetes Care will replace affected test strips at no
charge. Abbott Diabetes Care initiated this recall following a routine internal
quality review that indicated certain lots of Precision Xtra, Precision Xceed
Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima blood glucose test
strips may experience longer than normal blood fill times which may cause
falsely low blood glucose readings.
Customers are advised to contact their health care provider to determine testing
options if they do not have any unaffected test strips to use.
However, if consumers must use affected test strips while in the process of
obtaining new strips, they should:
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Check the amount of time it takes for their blood glucose meter to start the
“countdown” after they first apply blood to the test strip. They should start
timing immediately after blood first makes contact with the test strip. If the
meter takes longer than five seconds to start the countdown, that test strip
is affected and the result should not be used. Users should check the time for
each test strip they use because all of the strips in a package may not be
affected to the same degree. If any reading appears lower than they would
expect or does not seem to correlate with the way they are feeling, the user
should contact their health care provider immediately.
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If they do not immediately have access to unaffected strips and are unable to
test their blood sugar, users need to be aware of symptoms of high blood sugar
(hyperglycemia) and low blood sugar (hypoglycemia).
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Symptoms of high blood sugar include excessive thirst, excessive urination,
blurred vision, weakness, nausea, vomiting, and abdominal pain. If a user is
experiencing any of these symptoms or is not feeling well, they should
contact their health care professional immediately.
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Symptoms of low blood sugar may include trembling, excessive sweating,
weakness, hunger, confusion, and headache. Some individuals may have no
symptoms at all before they develop unconsciousness or seizures. It is
important to treat low blood sugars promptly to avoid loss of consciousness
or a seizure. If a user is unable to obtain unaffected strips, they should
contact their health care provider for advice on how to treat these symptoms
before they occur.
The recommendation is that hospitals and user facilities stop using the recalled
test strips and follow the steps below:
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Use test strips from unaffected lots.
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If the health care facility does not have any test strips from unaffected lots
but has an alternative point-of-care blood glucose testing system, begin using
the alternative system until new, unaffected test strips can be obtained.
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If the health care facility does not have any test strips from unaffected lots
or immediate access to an alternative point-of-care blood glucose testing
system, health care providers should take the following steps:
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Verify any critical glucose test results (e.g., test results that may be
used to adjust insulin therapy in vulnerable patient populations) generated
on the Precision Xceed Pro Blood Glucose Monitoring System using a central
laboratory blood glucose method. Clinical judgment should be applied when
deciding whether to act on results prior to verification.
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Verify any Precision Xceed Pro Blood Glucose Monitoring System results that
do not match a patient’s symptoms, or seem unexpected for the patient’s
clinical status, using a central laboratory blood glucose method.
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Monitor the amount of time it takes for the Precision Xceed Pro Blood
Glucose Meter to start the “countdown” after blood is first applied to the
test strip. If the amount of time exceeds five (5) seconds, discard that
test strip immediately because the blood glucose result may be erroneously
low. In addition, if this occurs:
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Note the specific lot number of that test strip;
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Notify Abbott Diabetes Care to report the observed problem with that lot
by calling 1-877-529-7185;
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Make sure to check fill time on each individual strip during use and do
not assume if one strip in a package/lot appears to be unaffected, that
all strips in that package/lot are unaffected.
Customers can check if they have test strips from the affected lots by visiting
www.precisionoptiuminfo.com and looking up their product lot number.
Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and
ReliOn Ultima customers can also get information by calling Abbott Diabetes Care
customer service at 1-800-448-5234 (English) and 1-800-709-7010 (Español).
The website and customer service phone numbers listed above will also provide
customers with information about returning affected test strips.
Unaffected Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium,
OptiumEZ and ReliOn Ultima Blood Glucose Test Strip lots may be used by
customers to test their blood glucose as directed by their health care
providers.
Abbott Diabetes Care has reported this situation to the U.S. Food and Drug
Administration and is working to make the necessary corrective actions to
prevent this situation from recurring.