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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 Recall
Precision Xtra Blood Glucose monitoring system
see related information
Date Posted June 07, 2007
Recall Status1 Terminated on April 04, 2008
Recall Number Z-0856-2007
Recall Event ID 37538
Product Classification System, Test, Blood Glucose, Over The Counter - 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, California 94502-7000
Manufacturer Reason
for Recall
The front button covers may detach from the meter.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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