Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Roche Coaguchek XS Plus

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Roche Coaguchek XS Plus see related information
Date Initiated by Firm July 22, 2009
Date Posted September 03, 2009
Recall Status1 Terminated 3 on April 27, 2011
Recall Number Z-2004-2009
Recall Event ID 52724
510(K)Number K071041  
Product Classification Test, time, prothrombin - Product Code GJS
Product Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis, IN; Model Number 05021537001.

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 1,327 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
-
-