recall

DonnaAnn
By DonnaAnn Latest Reply 2008-10-24 06:39:08 -0500
Started 2008-10-22 10:22:05 -0500

did anyone get a letter in the mail stating that some strips are being recalled because they are bad and can give false readings?


12 replies

Toma
Toma 2008-10-23 04:26:34 -0500 Report

Bayer Diabetes Care has issued a voluntary recall on certain lots of test strips designed for use with its Contour TS blood glucose meter. Blood glucose monitoring performed with the faulty test strips may produce readings that are 5% to 17% higher than actual blood glucose levels.

The recall is effective in the seven countries where the Contour TS meter is marketed: France, Turkey, Austria, India, Korea, Mexico, and the United States (where, according to Bayer, it is sold mostly by mail order). Strips that are used with other Bayer meters, such as the Ascensia Contour and the Ascensia Breeze 2 systems, are not affected.

If you use the Contour TS blood glucose meter, you can find out if your test strips are affected by the recall by checking the lot numbers on your bottles of strips. Lot numbers can be found on the side of the bottle containing the strips as well as on the bottom of the box that the bottles come in. The lot numbers of affected strips start with the letters WK, are followed by the characters 7D, 7E, 7F, or 7G, and are then followed by a series of other numbers and letters. (According to Bayer, an example of an affected lot number would be WK7ED3E52C.) Bottles with lot numbers beginning with WK followed by 7J through 7M are not affected and do not need to be returned. In all, 53 production lots of strips are being recalled, with a total of 230,000 bottles of strips affected.

If your test strips match any of the recalled lot numbers, you can call Bayer customer service at (800) 348-8100 to return affected bottles and get replacements. You can also visit www.bayerdiabetes.com/us/news/contourtsrecall... for more information about the recall. According to the company, the manufacturing problem that caused faulty test strips to be produced has been fixed and additional quality control measures are in place to prevent such a mistake from occurring again.

Toma
Toma 2008-10-23 04:24:35 -0500 Report

Counterfeit blood glucose test strips found on U.S. market
Monday, October 16, 2006 | 10:43 AM ET

U.S. consumers are being warned that counterfeit blood glucose test strips used by people with diabetes have slipped into the marketplace.

Use of the counterfeit strips with certain models of LifeScan, Inc. One touch Brand Blood Glucose Monitors might give inaccurate blood glucose readings, which could cause a patient to take either too much or too little insulin. No injuries have been reported to the FDA.

The counterfeit strips are:
· One Touch Basic/Profile (lot #272894A, 2619932 or 2606340) test strips.
· One Touch Ultra (lot #2691191) test strips.

Quebec-based Medical Plastic Devices and Champion Sales in New York distributed the counterfeit strips to pharmacies and stores across the United States.

Diabetics who have purchased the counterfeit test strips should stop using them, replace them, and contact their health practitioner and the company at 1-866-621-4855.

The FDA does not know how many of the phoney test strips were sold.

Health Canada reports that the counterfeit Lifescan One Touch Test Strips (Basic and Ultra) have not been distributed in Canada.

Lanore
Lanore 2008-10-23 06:36:43 -0500 Report

Thank you Toma I didn't relize it was for the basic meter. My letter was for the utlra only. Will be checking my strips. Lanore ;-)

Toma
Toma 2008-10-23 04:22:44 -0500 Report

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.

Lanore
Lanore 2008-10-23 03:20:00 -0500 Report

I received the letter as well, I believe it was for the one touch ultra Strips. I will see if I still have the letter. Since I don't use that meter i use one touch basic, I may have thrown it out. Lanore ;-)

John Crowley
John CrowleyCA 2008-10-22 11:08:53 -0500 Report

Yes, we got the letter. It is from LifeScan who makes the OneTouch meters. Ironically, we don't use those strips anymore. I'll try to remember to post the info on here. Unless you (DonnaAnn) have it. Could you post it?

Gabby
GabbyPA 2008-10-22 11:19:44 -0500 Report

There is a disucssion posted by Namvet that has the form or something for lifescan. I did not really understand the post, but I think it was for a free meter. Is this the same thing?

DonnaAnn
DonnaAnn 2008-10-22 22:14:24 -0500 Report

no Gabby, it is not, sadly enough. And John, I no longer have the letter, sorry.
Gabby, the letter stated that if you had the one touch meter with a certain code numbeer, the strips were bad and could give you a false reading. Another good reason to have more than one meter i guess!

John Crowley
John CrowleyCA 2008-10-24 06:39:08 -0500 Report

Here are the details:

A 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

Next Discussion: Hospital Scare! »