November 18, 2013
Freestyle Lite® Test Strips
Dear Valued Customer,
Recently, it has come to our attention that certain lots of
FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips produce erroneously
low blood glucose results when using FreeStyle® Blood Glucose Meters, FreeStyle
Flash® Blood Glucose Meters and the FreeStyle® blood glucose meter built into
the OmniPod® system. Erroneously low results that are not recognized may pose
significant risks to your health.
If you do not use the meters listed below, your blood
glucose results are not affected and you do not need to read further.
FreeStyle Flash® Blood Glucose Meter
FreeStyle® Blood Glucose Meter
The FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips
lots listed below may give out of range control solution results and produce
erroneously low blood glucose results when using the Blood Glucose Meters
1281732, 1283345, 1283603, 1285007, 1350414, 1363015,
1363109, 1363321, 1365056, 1365920, 1365921, 1365934, 1366006, 1366111,
1366337, 1366347, 1366515, 1367917, 1373262, 1374907
A test strip insert is included with every carton of test
strips, and provides very important product information. Please read your
test strip insert carefully to ensure that you are using the correct Blood
Glucose Meter for your test stroip type.
If you have affected product, we recommend you take
the following steps:
Abbott Diabetes Care Customer Service immediately at 1-888-736-9869 for
replacement of the affected test strips. When you call, Abbott will send you
unaffected FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips at no
waiting for your replacement strips to arrive, either use an alternate method
to measure your blood glucose (such as test strips from an unaffected lot
number or a different blood glucose monitoring system). This issue only
affects the lot numbers which are detailed in the list above when using
FreeStyle® Blood Glucose Meters, FreeStyle Flash® Blood Glucose Meters.
If the only test strips available to you
are from affected lots, do not stop testing your blood glucose. Control
solution should be used to check the performance of your test strips and meter
until you receive your replacement test strips. However, if any reading from a
strip appears lower than you would expect or does not seem to match the way you
are feeling, you should contact your health care provider. Pay special attention
to signs and symptoms of high blood sugar (hyperglycemia).
Symptoms of high blood sugar may
include: excessive thirst, excessive urination, blurred vision, weakness,
nausea, vomiting, and abdominal pain. If you are experiencing any of these
symptoms or are not feeling well, contact your health care professional
dispose of the test strips in accordance with your local and state disposal
If the lot number of the test strips
you are using is NOT in the table on this letter, you may continue to
test your blood glucose as directed by your health care provider with your
FreeStyle® Blood Glucose Test Strips.
There are no other Abbott Diabetes Care
products impacted by this issue.
We recognize the importance of blood
glucose testing and are committed to responding quickly to customers’ requests
for replacement test strips.
We want to assure you that our first
priority is you, our customer. We sincerely regret any inconvenience this
situation may cause. We thank you for your continued support of the FreeStyle
Blood Glucose Monitoring System and Abbott Diabetes Care. If you have any
further questions, please call Abbott Diabetes Care Customer Service at
Kelly E. Duffy
Division Vice President, Quality Assurance
Abbott Diabetes Care