Class 2 Device Recall AccuChek Aviva

• Date Initiated by Firm: November 09, 2005
• Date Posted: January 24, 2006
• Recall Status: Terminated on June 14, 2007
• Recall Number: Z-0423-06
• Recall Event ID: 33862
• 510(K)Number: K043474
• Product Classification: Glucose Dehydrogenase, Glucose - Product Code LFR
• Product: Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532275001. (Distributed within the U.S.)
• Code Information: Aviva meter serial numbers 52500000000 through 52510999999.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: 800-858-8072
• Manufacturer Reason for Recall: Incorrect patient blood glucose test results may be reported due to a software problem.
• FDA Determined Cause: Other
• Action: Notification letters dated 11/9/05 were issued to Users, Mail Order Distributors, Clinical Trial Sponsors, Pharmacists and Health Care Professionals. Press release issued 1/17/06.
• Distribution: Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.
• 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 = LFR and Original Applicant = ROCHE DIAGNOSTICS CORP.