|
Class 2 Device Recall Roche Coaguchek XS |
|
Date Initiated by Firm |
July 22, 2009 |
Date Posted |
September 03, 2009 |
Recall Status1 |
Terminated 3 on April 27, 2011 |
Recall Number |
Z-2003-2009 |
Recall Event ID |
52724 |
510(K)Number |
K062925
|
Product Classification |
Test, time, prothrombin - Product Code GJS
|
Product |
Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837738001.
CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication. |
Code Information |
All serial numbers. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Operations, inc. 9115 Hague Rd Indianapolis IN 46256-1025
|
For Additional Information Contact |
317-576-2000 Ext. 249
|
Manufacturer Reason for Recall |
The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
|
FDA Determined Cause 2 |
Device Design |
Action |
Roche Diagnostics Operations, Inc. notified Consignees by letter dated July 22, 2009 informing them of the problem and instructing them to use revised cleaning procedures.
For further questions, contact Roche Diagnostics Operations, Inc. at 1-317-521-3194. |
Quantity in Commerce |
27,784 in US |
Distribution |
Worldwide Distribution |
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 = GJS and Original Applicant = ROCHE DIAGNOSTICS CORP.
|
|
|
|