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U.S. Department of Health and Human Services

Class 2 Device Recall AccuChek Aviva

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  Class 2 Device Recall AccuChek Aviva see related information
Date Initiated by Firm November 09, 2005
Date Posted January 24, 2006
Recall Status1 Terminated 3 on June 14, 2007
Recall Number Z-0419-06
Recall Event ID 33862
510(K)Number K043474  
Product Classification Glucose Dehydrogenase, Glucose - Product Code LFR
Product Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04528247001. (Distributed within the U.S.)
Code Information For the quantitative measurement of the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals.
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 2		 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.
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