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U.S. Department of Health and Human Services

Class 2 Device Recall Roche Coaguchek XS

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 Class 2 Device Recall Roche Coaguchek XSsee related information
Date Initiated by FirmJuly 22, 2009
Date PostedSeptember 03, 2009
Recall Status1 Terminated 3 on April 27, 2011
Recall NumberZ-2003-2009
Recall Event ID 52724
510(K)NumberK062925 
Product Classification Test, time, prothrombin - Product Code GJS
ProductRoche 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.
FEI Number 1823260
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
ActionRoche 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 Commerce27,784 in US
DistributionWorldwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GJS
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