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U.S. Department of Health and Human Services

Class 3 Device Recall Precision Xtra Blood Glucose monitoring system

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  Class 3 Device Recall Precision Xtra Blood Glucose monitoring system see related information
Date Initiated by Firm March 05, 2007
Date Posted June 07, 2007
Recall Status1 Terminated 3 on April 04, 2008
Recall Number Z-0856-2007
Recall Event ID 37538
510(K)Number K033845  K040814  
Product Classification Blood Glucose monitoring system. Individual test meter and test strip kit. - Product Code NBW
Product Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit.
Code Information Other Brand names include: Precision Xceed Blood Glucose Monitoring system, Optium Xceed, Omron, HEA-214, Optium Xido, MediSense Optium, Boots, Optium (includes Medline and Liberty), Kroger, ReliOn, Rite Aid.
Recalling Firm/
Manufacturer		 Abbott Diabetes Care, Inc.
1360 S Loop Rd
Alameda CA 94502-7000
Manufacturer Reason
for Recall		 The front button covers may detach from the meter.
FDA Determined
Cause 2		 Other
Action The firm intends to send letters to all customers that have registered their units under the firm's warranty database and the firm's first consignees. In addition, this notification will be placed on the company website, with e-mail and phone contacts as needed. Letter dated March 5, 2007.
Quantity in Commerce approximately 300 lots
Distribution Product was distributed worldwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = ABBOTT LABORATORIES
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