[IP] LifeScan Recalls Specific Lots of Consu mer and Professional OneTouch® SureStep® Te st Strips Due To Inaccurate]

[John S Wilkinson <email @ redacted>]

LifeScan Recalls Specific Lots of Consumer and 
Professional OneTouch.
SureStep. Test Strips Due To Inaccurate
Recall -- Firm Press Release



FDA posts press releases and other notices of 
recalls and market withdrawals from the firms 
involved as a service to consumers, the media, and 
other interested parties. FDA does not endorse 
either the product or the company.


LifeScan Recalls Specific Lots of Consumer and 
Professional OneTouch. SureStep. Test Strips Due 
To Inaccurate Readings at High Levels



Contact:
David Detmers, LifeScan, Inc.,
+1-408-942-5955



FOR IMMEDIATE RELEASE -- MILPITAS, Calif., Feb. 24 
/PRNewswire/ -- LifeScan, Inc. is conducting a 
voluntary recall in the United States of eight 
lots of OneTouch. SureStep. Test Strips, used by 
people with diabetes to measure their blood 
glucose levels at home. The test strips are being 
recalled because they may provide falsely low 
glucose results when the glucose level is higher 
than 400 mg/dL.

The eight lots of consumer OneTouch SureStep Test 
Strips being recalled are:
Recalled Lot 	Size 	Description
# 2969251 	100-ct 	OneTouch SureStep
# 2969798 	100-ct 	OneTouch SureStep
# 2982369 	100-ct 	OneTouch SureStep
# 2983467 	100-ct 	OneTouch SureStep
# 2969795 	50-ct 	OneTouch SureStep
# 2982566 	50-ct 	OneTouch SureStep
# 2969481 	50-ct 	Medicare/Mail Order
# 2998193 	50-ct 	Medicare/Mail Order



Lot #'s are located on the outer carton and test 
strip vial.

Patients with test strips from the recalled lots 
are asked to call LifeScan at 800 574-6139 between 
5:00 am and 7:00 pm Pacific Time, seven days a 
week or visit www.SureStep.com to request 
replacement product. Replacement product will be 
shipped immediately and provided free of charge.

While waiting for replacement product to arrive, 
it is important that patients with recalled test 
strips continue to test their blood glucose. 
Patients with access to a meter that does not use 
OneTouch SureStep Test Strips should use this 
other meter to test their blood glucose until 
replacement product from LifeScan arrives. If an 
alternate meter is not available, patients may 
continue to test using the recalled OneTouch 
SureStep Test Strips. However, if patients obtain 
results above 400 mg/dL, they should contact their 
healthcare professional for further instructions 
because their glucose may be significantly higher.

LifeScan estimates approximately fourteen thousand 
packages (50- and 100-count) of consumer OneTouch 
SureStep Test Strips were distributed nationwide 
between August 1, 2009 and January 28, 2010.

No injuries associated with these recalled test 
strips have been reported. However, if patients 
use the falsely low test results to determine 
their insulin dose, they may give themselves too 
little insulin, which could result in poor blood 
glucose control. Patients with high blood glucose 
may or may not have certain symptoms including 
increased thirst, frequent urination, headaches, 
difficulty with concentration, blurred vision and 
fatigue (weak, tired feeling). High blood glucose 
must be recognized and treated promptly to avoid 
serious complications, such as coma and death.

Hospitals, clinics and other multi-patient 
facilities using SureStep.Pro., SureStep.Flexx. or 
OneTouch. SureStep. Hospital Systems have also 
been notified of this issue. All three of these 
systems use SureStep.Pro. Test Strips which also 
may provide inaccurately low test results when the 
blood glucose reading is greater than 400 mg/dL. 
LifeScan has advised these facilities of the 
appropriate actions to take in order to continue 
to use these SureStepPro Test Strips. However, 
healthcare facilities with access to alternative 
means of testing should consider temporarily 
discontinuing their use of their SureStep Systems 
until replacement test strips are available.

This field action is limited to eight lots of 
OneTouch SureStep Test Strips sold for consumer 
use in the U.S., and select SureStepPro Test 
Strips used in healthcare facilities. Similar 
recall actions are being taken in other countries 
where the affected product was distributed.

In 2006 LifeScan stopped selling OneTouch SureStep 
Meters in the U.S. but continued to provide test 
strips. Today, OneTouch SureStep Meter users 
represent a very small portion of LifeScan's total 
customer base. The vast majority of LifeScan's 
customers now use OneTouch. Ultra. Brand Meters, 
which use an entirely different technology.

LifeScan, Inc. is a leading maker of blood glucose 
monitoring systems for people with diabetes. For 
information about diabetes care and LifeScan 
products and services, visit 
www.OneTouchDiabetes.com1.

CONTACT: David Detmers, LifeScan, Inc., 
+1-408-942-5955
/Fri, 26 Feb 2010 10:13:00 -0600/

LifeScan, Inc. is conducting a voluntary recall in 
the United States of
eight lots of OneTouch. SureStep. Test Strips, 
used by people with
diabetes to measure their blood glucose levels at 
home. The test strips
are being recalled because they may provide 
falsely low glucose results
when the glucose level is higher than 400 mg/dL.

------------------------------------------------------------------------

Manage your FDA Subscriptions:

     * Update your preferences or unsubscribe
 

<http://links.govdelivery.com:80/track?type=click&enid=bWFpbGluZ2lkPTczMTQ2MyZtZXNzYWdlaWQ9UFJELUJVTC03MzE0NjMmZGF0YWJhc2VpZD0xMDAxJnNlcmlhbD0xMjE1Njk3MTMxJmVtYWlsaWQ9andpbGtpbnNAdHdjbnkucnIuY29tJnVzZXJpZD1qd2lsa2luc0B0d2NueS5yci5jb20mZXh0cmE9JiYm&&&101&&&https://service.govdelivery.com/service/user.html?code=USFDA>

     * Questions about this service? 
email @ redacted
       <mailto:email @ redacted>
     * Other inquiries? email @ redacted 
<mailto:email @ redacted>

GovDelivery, Inc. sending on behalf of U.S. Food & 
Drug Administration
(FDA) 7 5600 Fishers Lane 7 Rockville MD 20857 7 
800-439-1420


-- 
John S Wilkinson
Rome, NY
.
----------------------------------------------------------
for HELP or to subscribe/unsubscribe/change list versions,
contact: HELP@insulin-pumpers.org