Date Initiated by Firm |
November 09, 2005 |
Date Posted |
January 24, 2006 |
Recall Status1 |
Terminated 3 on June 14, 2007 |
Recall Number |
Z-0426-06 |
Recall Event ID |
33862 |
510(K)Number |
K043474
|
Product Classification |
Glucose Dehydrogenase, Glucose - Product Code LFR
|
Product |
Roche brand Accu-Chek Aviva Meter (mmol/L); Catalog numbers 03532313001 and 03532321001. (Distributed outside of the U.S.) |
Code Information |
Aviva meter serial numbers 52600000000 through 52610999999, 52700000000 through 52710999999 and 52800000000 through 52810999999. |
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.
|