Test Strips CLASS 1 FDA RECALL

Diabetics often have some of the greatest needs for a wide variety of medications and medical supplies on an ongoing basis.
FORUM RULES: It is important not to do anything immoral, unethical, illegal, or against your doctor's advice.

Not all methods posted here will work. These are simply ideas some people have found to be useful.

We require polite behavior on this forum. (otherwise your posts will be eliminated and you will be restricted).

The Disclaimer page carefully explains about how the information you find on this site can be safely used. Follow its guidelines & it can help prevent problems. Don't blindly follow advice found here. Consult your doctor or a qualified licensed medical provider before using ANY information, ideas, or methods of saving money on meds to help ensure they are safe for your own health issues. Any information on this website is used at your own risk. Click here to read our Disclaimer.

Test Strips CLASS 1 FDA RECALL

Postby jimithy » Sun Feb 20, 2011 10:35 am

Minor recall in Dec 2010 has become a major recall due to potential harm to users. I called. You must have your boxes of strips' lot numbers (on the end of the box) for them to decide whether they will replace your strips.

Abbott Glucose Test Strips
Recall Class: Class I
Date Recall Initiated: December 22, 2010
Products: Glucose Test Strips
Precision Xceed Pro
Precision Xtra
Medisense Optium
Optium
OptiumEZ
ReliOn Ultima
The above first five test strips are used with Abbotts’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium and OptiumEZ blood glucose monitoring systems. ReliOn Ultima test strips are used with the ReliOn Ultima blood glucose monitoring system.
The blood glucose monitors are not being recalled and customers can continue using them. Other Abbott Diabetes Care products are not affected by this recall.
To locate the test strip lot numbers affected by this recall, visit http://www.precisionoptiuminfo.com or see the Firm Press Release under Additional Links below.
These test strips were manufactured between January and September 2010 and were sold both in retail and online settings directly to consumers, but were also used in health care facilities.
Use: These products are used to monitor blood glucose levels.
Recalling Firm:
Abbott Diabetes Care, Inc.
1360 South Loop Road
Alameda, California 94502-7000
Reason for Recall: These test strips may give falsely low glucose results. False results may lead patients or health care providers to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading. Use of these products may cause serious health consequences including death.
Public Contact:
Consumers:
For questions, call Abbott Diabetes Care customer service at 1-800-448-5234 (English) and 1-800-709-7010 (Spanish) to speak with a customer service representative.
Health Care Professionals:
If using the Precision Xceed Pro Blood Glucose System, notify Abbott Diabetes Care to report observed problems (note specific lot number of the test strip) by calling 1-877-529-7185.
FDA District: San Francisco
FDA Comments:
On December 22, 2010, the firm sent a recall letter to its customers and also issued a press release. The firm explained the reasons for the recall and requested the products be returned.
Consumers and Health Care Professionals who used these test strips, see recommendations found in the FDA News Release or in the Firm Press Release under Additional Links below.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s Safety Information and MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.
jimithy
Site Admin
 
Posts: 378
Joined: Thu Oct 12, 2006 11:36 am
Location: The beautiful mountains of S. West Virginia!

Re: Test Strips CLASS 1 FDA RECALL

Postby jimithy » Sun Feb 20, 2011 4:56 pm

I called and found that the strips I am currently using plus 200 strips I haven't opened are part of the recall.

They are sending replacement strips within 7 days.
jimithy
Site Admin
 
Posts: 378
Joined: Thu Oct 12, 2006 11:36 am
Location: The beautiful mountains of S. West Virginia!


Return to Diabetes and Disorders & Syndromes You Get Because Of It.

Who is online

Users browsing this forum: No registered users and 1 guest

cron