Recall, one touch sure step strips (& below, OTU strips)

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Re: Recall, one touch ultra sure step strips

Thank you Deb. The text for those who want to see it here:

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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 http://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 http://www.OneTouchDiabetes.com1.

CONTACT: David Detmers, LifeScan, Inc., +1-408-942-5955
Click to expand...
 
Another One Touch Ultra Test Strips Problem

I received an email yesterday from Lifescan about 900 packages of One Touch Ultra Test Strips having the wrong strips enclosed in them: http://links.mkt1104.com/servlet/Ma...r=NTQwMzUwNTE2NwS2&j=MTUyNDM1MjAwS0&mt=1&rt=0 You'll have to open the link to see the pictures.

February 4, 2010

Urgent Medical Device Correction
OneTouch® Ultra® Test Strips

Dear Valued Customer:

At LifeScan we hold our products to the highest standards of quality; constantly working to ensure they provide glucose results you can rely on. For that reason, we're also committed to communicating with you when we learn of product that does not meet our expected standards.

We have recently determined that up to 900 OneTouch® Ultra® Test Strip Packages contain vials of the wrong test strip. These incorrect test strips can be easily identified because they are dark blue and don’t have a brand name printed on the strip (See Picture 1). As a safety feature, these strips will not turn on your OneTouch®Ultra® Brand meter or provide a test result.

These mislabeled test strips are found only in 100-count packages (4 vials of 25 test strips each) of OneTouch Ultra Test Strips with Lot # 2964512. All other 25-, 50- and 100-count packages of OneTouch Ultra Test Strips are unaffected.


Picture 1
Our priority is to make sure you have only OneTouch Ultra Test Strips so that you can test your blood glucose with confidence as recommended by your healthcare professional.
Please check your OneTouch Ultra Test Strips to see if you have any test strips from lot # 2964512. The lot number can be found on both the vial label and the outer carton (Picture 2). If you have any test strips from this lot, please compare the test strips in each vial with the strips in Picture 1 to confirm they are OneTouch Ultra Test Strips.

If you discover any mislabeled test strips, do not try to use them. Please click here for further instructions to receive replacement product free of charge.If you still have questions, you may also contact LifeScan Customer Service by calling our special phone number: 866 247-1029 between 8:00 a.m. to 5:00 pm PT, Monday through Friday. Even if you do not have any mislabeled test strips, please visit http://www.OneTouchProductID.com to make sure your meter registration and contact information - including email address - is current so that we can continue to bring you important information in the future.

Lot Number Location

Picture 2
We apologize for any inconvenience this issue may cause and have already taken steps to prevent it from recurring in the future. Thank you for your continued support of LifeScan.

Sincerely,

LifeScan Customer Service

Please note our current Customer Service Hours are 5:00 a.m. - 7:00 p.m. PT, 7 days a week.

LifeScan, Inc. * 1000 Gibraltar Dr * Milpitas, CA 95035-6312
 
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