OneTouch Ultra Strips recalled

[k9diabetes]

From Louise at the Cushings Board (www.caninecushings.net)

I received a letter from LifeScan today (dated Sept. 19 by the way) regarding a recall of the One Touich Ultra Test Strips 25-count. I am a user of this product and I immediately thought of the doggies with diabetes who are being tested with these strips. I looked over at the FDA website and there was no recall notice yet.

Here's the pertinent information:

This letter is to let you know that LifeScan is voluntarily removing and offering to replace 25-count One Touch Ultra Blood Glucose Test Strips with a lot number on the package of 2829235. We are replacing them because we have learned that a very small number of vials in this lot may contain strips that could produce inaccurately low blood glucose test results.

We have also informed the U.S. Food and Drug Administration of this action.

Please note that this concern only applies to a very limited quantity of the 25-count packages.

If you only use 50 or 100 count packages of One Touch Ultra Test Strips, or if your 25-count test strips do not have a lot number of 2829235, please note that your test strips are not affected by this issue and that you can continue to use them with confidence to test your blood glucose.

If you do have One Touch Ultra Test Strips from Lot number 2829235, please discontinue their use and call LifeScan at 1 (866) 247-1281 to receive replacement test strips.

[We Hope]

Re: OneTouch Ultra Strips recalled

This is important as there's nothing at FDA but we now have the link about the strips from LifeScan, makers of OneTouch Ultra:

http://www.lifescan.com/company/abou...tstrips092008/

Letter to OneTouch® Ultra® Test Strip Customers
--Urgent Medical Device Recall: OneTouch Ultra Test Strips- 25-count from Lot #2829235 Only--

September 19, 2008

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 may not be performing to our expected standards.

If you use OneTouch® Ultra® Test Strips to test your blood glucose, have patients who use them, or distribute or sell OneTouch Ultra Test Strips, please be aware that LifeScan is voluntarily removing and offering to replace 25-count OneTouch Ultra Blood Glucose Test Strips with a lot number on the package of 2829235. We are replacing them because we have learned that a very small number of vials in this lot--sold only in the United States--may contain strips that could produce inaccurately low blood glucose test results.

Please note that this concern only applies to a very limited quantity of the 25-count packages sold in the United States from Lot 2829235.

If you only use 50- or 100-count packages of OneTouch Ultra Test Strips or if your 25-count test strips do not have a lot number of 2829235, your test strips are not affected by this issue and you can continue to use them with confidence to test your blood glucose.

How to Tell If Your OneTouch Ultra Test Strips Are Affected

Please check the lot numbers of any 25-count OneTouch Ultra Test Strips in your possession. The lot number appears on the outside of the test strip box and on the label of the test strip vial.

If you do not have any product from OneTouch Ultra Test Strip Lot 2829235, then your test strips are not subject to this recall and no further action is required. You can continue to use your test strips to test your blood glucose.

Do Not Use OneTouch Ultra Test Strips from Lot 2829235 - Call LifeScan

If you do have OneTouch Ultra Test Strips from Lot number 2829235, please discontinue their use and call LifeScan to tell the customer service representative that you have test strips that need to be replaced. You should also tell the representative if you have other test strips available to test with while you wait for replacement strips. The LifeScan representative will provide information on how you can return your test strips from Lot 2829235 and will make arrangements for any replacement test strips.

Please know that LifeScan takes this issue very seriously. We continually strive to ensure that we provide you with product of the highest quality. In addition, we have informed the U.S. Food and Drug Administration of this situation and the steps we have taken to resolve it.

We apologize for any inconvenience this issue may cause. Thank you for your continued support of LifeScan.

How to Contact LifeScan

People with diabetes
Telephone: 866 693-0602
Health Care Professionals
Telephone: 866 693-0598

Retailers/Distributors
Telephone: 866 693-0597



Kathy

[We Hope]

Re: OneTouch Ultra Strips recalled

A reminder-

http://www.fda.gov/bbs/topics/ENFORC.../ENF01083.html

FDA Enforcement Report November 26, 2008

PRODUCT

One Touch Ultra Test Strips, part number 020-994-02, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use 0outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm, Recall # Z-0004-2009

CODE

Lot number: 2829235

RECALLING FIRM/MANUFACTURER

Lifescan Inc., Milpitas, CA, by letters, dated September 19, 2008. Firm initiated recall is ongoing.

REASON

Products exceed inaccuracy threshold, with many complaints resulting from inaccurate low results.

VOLUME OF PRODUCT IN COMMERCE

35,308 vials

DISTRIBUTION

Nationwide and PR