Class I Medical Device Recall: Abbott Glucose Test Strips
Posted Feb 15 2011 12:00am
Recall Class: Class I
Date Recall Initiated: December 22, 2010
Products: Glucose Test Strips
Precision Xceed Pro
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 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.
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
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.