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U.S. Department of Health and Human Services

Class 2 Device Recall CoaguChek XS Pro System

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  Class 2 Device Recall CoaguChek XS Pro System see related information
Date Initiated by Firm May 16, 2013
Date Posted June 24, 2013
Recall Status1 Terminated 3 on April 16, 2014
Recall Number Z-1582-2013
Recall Event ID 65246
510(K)Number K093460  
Product Classification Test, time, prothrombin - Product Code GJS
Product CoaguChek XS Pro System

The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).
Code Information Model/Catalog/Part Number: 05530199160
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Todd Siesky
317-521-3911
Manufacturer Reason
for Recall		 Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.
FDA Determined
Cause 2		 Software design
Action Rochet sent an Urgent Medical Device Correction letter dated May 16, 2013, via UPS Ground to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were issued the following instructions: If you are using Warfarin therapy in combination with antibiotics and/or chemotherapy drugs, which could potentially lead to an extremely high test result (> 10 INR), you may in rare cases receive repeated ERROR 6 messages instead of a test result. If the ERROR 6 message is displayed repeatedly on your CoaguChek XS meter, immediately contact your treating physician. The CoaguChek XS PT Test Strip package insert; the online version of the CoaguChek XS PST system users manual; and the CoaguChek XS systems are being updated to provide additional ERROR 6 message information and actions. Updated versions will be available on the www.poc.roche.com website by the end of June 2013. Health Care Professionals are instructed to use an alternative method to determine INR results if an ERROR 6 message is displayed repeatedly on the CoaguChek XS, CoaguChek XS Plus, or CoaguChek XS Pro meters for the same patient. Self testing patients are instructed to contact their Health Care provider immendiately if the ERROR 6 message is displayed repeatedly on the CoaguChek XS. Please contact your Roche Account Manager or Roche Diagnostics Point of Care Technical Service, 24 hours a day, seven days a week at 1-800-428-4674 if you have questions about the information contained in this UMDC. For questions regarding this recall call 317-521-3711.
Quantity in Commerce 537 meters total
Distribution Nationwide 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
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